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Transfer MU
Type : DLV-TP-MU
Material : Titanium
Color : Silver Black
Use : Dental
Thickness : 2.5mm-5mm
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Titanium Sleeve MU
Material : Titanium
Type : DLV-TS-MU
Color : Silver Black
Use : Dental
Shape : Round
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Temporary Abutment
Type : DLV-TA
Color : Silver Black
Shape : Round
Use : Dental
Material : Metal
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Straight MU
Material : Metal
Use : Dental
Color : Silver
Shape : Round
Type : DLV-ST-MU
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Straight Abutment
Range : DLV-SS-9mm DLV-S-1mm DLV-S-2mm DLV-S-3mm DLV-S-4mm
Color : Silver
Material : Titanium
Use : Dental
Thickness : 2.55mm
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Open Tray
Type : DLV-OP
Material : Metal
Color : Silver
Application : Dental
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Implant Analog
Application : Dental Sugery
Type : DLV-IA
Color : Silver
Material : Metal
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Healing cap
Type : DLV-HC-3mm, DLV-HC-5mm
Material : Metal
Cover Cap MU
Type : DLV-CC-MU
Material : Metal
Feature : Good Quality
Color : Silver Black
Shape : Round
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Closed Tray
Type : DLV-CT
Color : Silver
Material : Metal
Application : Dental
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Casting Sleeve MU
Type : DLV-BS-MU
Material : Metal, Plastic
Use : Medical Instrument
Color : White, Silver
Thickness : 2-5mm
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Casting Abutment
Type : DLV-CA
Application : Medical Instruments
Color : White
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Ball System
Weight : 10-30g
Material : Metal
Color : Silver
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Angulated MU
Type : DLV-17-MU, DLV-30-MU
Color : Black Silver
Material : Metal
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Analog MU
Type : DLV-17-MU
Weight : About 50g
Color : Silver
Material : Metal
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Active+ Dental Implant
Active+® is a Calcium-Phosphate (CaP)-derived chemical component with faster bone recovery and immediate loading success rate. Active+® is an advanced implant that offer clear benefit to experienced users. Active+'s unique design offers high initial stability-even in compromised bone situations. Active+® complex surface design with significant surface enlargement enhances the coating procedure and provides: Higher primary stability Reduced healing time Active support of bone attachment Higher wettability with blood immediately loading Prevention of spontaneous oxidation of the surface Higher osteoconductivity of the surface DLV BIOCARE focused its research on the factor of surface roughness and we used various techniques in order to compare our results with the best, universally recognized implant manufacturers. The following results were obtained through metallographic implant surface cross-section analysis in two locations: the base and at the end of the implant. The analysis accurately determined the depth and width of the dimples, as well as their geometry which is clearly visible on the image bellow. The surface is well-developed with large and small dimples which enhance osseointegration. Active+® surface treatment combines Active Surface® and CaP and introduces much improved osseointegration by penetrating all of the pores and providing a strong bone anchoring to the surface (high BIC). Advantages : Optimal roughness characteristics quickly resorbable CaP Surface High primary stability Rapid bone ongrowth Reduce healing time Immediate implant loading
Material : Ti-6Al-4V (Titanium grade 5)
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25 Degree Angulated Abutment
Range : DLV-25AS-9mm DLV-25A-1 mm DLV-25A-2mm DLV-25A-3mm DLV-25A-4mm
Color : Silver
Use : Dental
Material : Metal
Size : 4mm - 9mm
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15 Degree Angulated Abutment
Rnage : DLV-1 5AS-9mm DLV-1 5A-1 mm DLV-1 5A-2mm DLV-1 5A-3mm DLV-1 5A-4mm
Type : Implantable
Material : Metal
Color : Silver
Use : Dental
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regulatory consulting services
Lati Consulting Services is operating as a reliable service provider and engaged in rendering the best in class solutions for Cosmetic Regulatory Services, Medical Device Regulatory Services, Drug Regulatory Services, Authorized Agent Services and Regulatory Submission Services. Whether you are a startup or a large multinational company, you can benefit from the experience and expertise of LCS to meet your objectives in a highly cost effective way. With our expertise in this arena, we provide complete assistance to help medical device, pharmaceutical, biotechnology and Cosmetics companies get their products to market quickly. LCS has provided support for more than 50 New Medical devices, 100 New Drug Application (NDA), Biologic License Application (BLA) and Abbreviated New Drug Application (ANDA) approvals and has provided drugdevice development services for new drugs devices in all major therapeutic areas. We provide resourceful methodical and regulatory consulting services to help ensure the continued success of your product post-approval.
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Regulatory submission services.
Clients prefer us for our sincerity in providing Regulatory Submission Services, our professional behavior and timeliness. Our services are appreciated for their excellence as well as we completion within the pre-defined time. Our experienced personnel are there to guide the clients and help them in meeting their exact requirements. As a trusted name, we work in complete coordination with the clients. Moreover, our services are available at reasonable charges. Our regulatory submission services include : •Drug submissions : IND, NDA, CTD, ANDAs etc. •Medical Device submissions : Registration Certificate, Import License, Test License, Clinical Trail application , shelf Life Approval, Model Addition to the existing registered Products, Notification and clarification for major and minor changes, adding new indication to already registered products, endorsement app to the Registration Certificate •Investigator’s Brochures and Briefing Documents •Clinical Trial Documentation : Protocols, Informed Consent Forms, and ICH-compliant Clinical Study Reports •Cosmetics Submission : Registration Certificate, Notification and clarification for major and minor changes, endorsement app to the Registration Certificate.
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Dossier preparation and compilation services.
Details : Our Consultants team provides accurate documentation compliant with guidelines and regulations. Our highly qualified staff will work closely with your team to produce precise documentation for a wide variety of drug therapeutic areas and medical device categories. Our staff have scientific degrees and have experiences in many therapeutic areas. Our Consultants team averages over 10 years of experience. And no matter what template, writing style or electronic document management system you follow, they will write and finalize documents within your specifications. Our regulatory submission services include : •Drug submissions: IND, NDA, CTD, ANDAs etc. •Medical Device submissions: Registration Certificate, Import License, Test License, Clinical Trail application , shelf Life Approval, Model Addition to the existing registered Products, Notification and clarification for major and minor changes, adding new indication to already registered products, endorsement app to the Registration Certificate •Investigator’s Brochures and Briefing Documents •Clinical Trial Documentation: Protocols, Informed Consent Forms, and ICH-compliant Clinical Study Reports •Cosmetics Submission: Registration Certificate, Notification and clarification for major and minor changes, endorsement app to the Registration Certificate
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Independent representation/India authorized agent services.
India authorized representative •in order to legally register, import and market, sell your medical products in india you need to be compliant to indian regulations and legislation. When a company does not have a registered and physical office with statutory personnel and required licenses in india, a legal india authorized representative agent with the above needs is to be formally appointed. This authorized representative will also be held responsible for pre-certification and post-market surveillance inquiries. •lcs will represent your organization as your official indian authorized representative agent in accordance with india applicable regulatory legislation: the drugs and cosmetics act and rules. •only one indian authorized representative office is needed for the whole country. Lcs will represent you legally in india without any commercial conflict of interest activities like product distribution, product marketing, product sales etc. retain full control over product distribution •many product distributors are happy to take on the role of an official indian authorized representative. This relationship would curtail the manufacturer’s ability to work with multiple distributors in india or change distributors due to performance challenges. •since the appointed india representative is identified on the cdsco product registration documents and tied to the manufacturing site and product approval for its three year duration, if a distributor is appointed as the authorized representative, this relationship cannot be changed at least for a period of three years. Also, this can become problematic because if you decide to switch distributors you will need to start the registration process all over again.
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Regulatory Strategy Services.
•The LCS regulatory affairs strategy is characterized by both efficient preparation and execution of development plans and interfacing with regulatory agencies. Our scientific and regulatory experts consider FDA guidance documents, requirements of the International Conference on Harmonization and other regulatory agencies, and currently marketed products to ensure attention to detail in the preparation and submission of regulatory documents. This strategy has successfully helped clients reduce development time and accelerate the movement of new products to proof-of-concept and global commercialization for medical devices, pharmaceuticals and biologics. The regulatory affairs experts at LCS have experience in all major therapeutic areas and have had successful interactions with all regulatory divisions within the regulatory agencies. Our team of industry-trained scientific and regulatory consultants will support your product throughout the entire development continuum, from concept and strategic development, to proof-of-concept and market approval, to post-approval maintenance. We provide regulatory affairs solutions for full product lifecycle management. Our regulatory expertise also includes solutions to help clients navigate the complex requirements for expedited programs.
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Drugs and medical devices regulatory services
•LCS’s consultants include former FDA officials and regulatory experts with industry experience. Our regulatory experts work with your company to provide a strategic analysis of your project to develop a realistic and well thought out plan with your goals in mind. Our strategic analysis includes a gap analysis based on the most current regulations requirements. •Our highly experienced regulatory consultants bring a wealth of knowledge of the most up-to-date regulations, directives, laws, policies, and guidelines. It is our job to sort through the details, interpret guidelines, and recommend the right course of action for your organization. •Many small and startup companies often cannot afford having their own regulatory departments. LCS is positioned to act as your Regulatory department on an “as needed” basis with significant cost savings. In serving your needs we provide value to your organization to avoid costly and sometimes irreversible mistakes. Our regulatory consulting includes but is not limited to : • Regulatory strategic planning from design to market (e.g., Fast Track, orphan drug, drug vs. cosmetic) • Product Classification Review (Devices, Drugs, Combination products) • FDA meeting management for key Milestone meetings with Regulatory Agencies • Medical devices regulatory support for Product Registration • Labeling & advertising review • Risk Management Plans • India Agent status for non-India Companies
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Cosmetics regulatory services.
•In India, the latest Cosmetics Import & Marketing regulatory mandate, enforced from 1st April 2013, requires registration of the manufacturing sites and the products with the Indian licensing authority - the CDSCO. This activity is an essential requirement to ensure that Cosmetics Manufacturers based outside of India, can Import and Market their products in India. •In brief, the cosmetics manufacturer needs to apply for the products' registration through their registered office in India, or their Subsidiary or through an Importer or a India based Authorised Agent. The actual application for product registration is submitted to the CDSCO, using "Form 42", the required essential documents and in the specified submission format. On successful review of the submitted dossier, the CDSCO will issue a "licence" in the form of a "Registration Certificate (RC)". •This issued Registration Certificate, is both manufacturing site and product list specific. The manufacturer, through his subsidiary or importer or a India based Authorised agent can import the list of products specified in the RC only from the manufacturing so specified in the RC. In other words this RC is the equivalent of an Import License or Market Authorisation. •LCS provides both Market Product Authorisation Services as well as Authorised Agent Services. An end-to-end service offering which will help you import and sell your product in India, so as to achieve faster product approvals leading to enhanced access to Markets and Opportunities. Product registration services include the following : •Regulatory Strategy Consulting and Liaison •Complete Product Life Cycle Management •Compilation of India specific submission dossiers •Submission management leading to approvals •India Specific Labelling and Instructions for Use leaflets •Post marketing services including Complaint handling, Query management & Submission activities •All statutory Marketing Authorization holder's requirements
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