Cotec Dental Implant System
510(k) K100511
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK100511 | Date9 Jul 2010 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DZE
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3640
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Cotec Dental Implant System is a dental implant device classified as an endosseous root-form fixture (21 CFR 872.3640). It consists of internal or submerged titanium fixtures and abutments designed for surgical placement into the mandible or maxilla to support dental prostheses. The fixtures incorporate Morse-tapered connections to enhance stress distribution and promote marginal bone preservation.
The system is supplied as a sterile, single-use implant kit for use in oral and maxillofacial surgical settings. Fixtures are available in identical sizes for both internal and submerged designs, fabricated from titanium metal. Authorized for use in the United States under FDA 510(k) clearance (K100511), the device adheres to dental implant standards and is intended for professional surgical application by trained clinicians.
Questions
AI-generated answers, 19 Sep 2026
What types of dental prostheses can the Cotec Dental Implant System support, and how does its design help with stability?
The Cotec Dental Implant System is designed to support dental prostheses such as crowns, bridges, or dentures by integrating with the mandible or maxilla. Its fixtures use an internal or submerged titanium design with a Morse-tapered connection, which distributes stress more evenly and helps preserve the marginal bone, improving long-term stability.
Is the Cotec Dental Implant System intended for reuse, or is it meant to be used only once per patient?
The Cotec Dental Implant System is supplied as a sterile, single-use implant kit. This means each kit is intended for one surgical procedure per patient, ensuring infection control and maintaining sterility standards for clinical use.
What materials are the fixtures made of, and why is this important for dental implants?
The fixtures in the Cotec Dental Implant System are fabricated from titanium metal. Titanium is widely used in dental implants due to its biocompatibility, corrosion resistance, and ability to integrate well with bone tissue, reducing the risk of rejection or complications.
How are the fixtures sized, and are there variations for different patient anatomies?
The Cotec Dental Implant System provides fixtures in identical sizes for both internal and submerged designs, meaning there is no variation in sizing between these two types. The system is designed to accommodate standard dental implant placements in the mandible or maxilla, but clinicians should select the appropriate size based on individual patient anatomy and surgical planning.
What surgical settings or specialties is this implant system approved for, and who should place it?
The Cotec Dental Implant System is authorized for use in oral and maxillofacial surgical settings. It is intended for professional surgical application by trained clinicians, such as oral surgeons, periodontists, or prosthodontists, who have experience with dental implant procedures.