Dental Implant, Carbon Coated Metal
510(k) K772304
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK772304 | Date3 Jan 1978 | 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- Withdrawn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
This device is an endosseous, root-form dental implant designed for osseointegration within the alveolar bone to support dental prosthetics. The carbon-coated metal surface enhances biocompatibility and integration with surrounding bone tissue, providing a stable foundation for fixed or removable dental restorations.
The implant is supplied as a sterile, single-use device intended for surgical placement by dental professionals in oral and maxillofacial settings. It adheres to FDA 510(k) clearance (K772304) under regulation 872.3640, classified as a Class II medical device. No additional MRI safety or reuse specifications are noted in the regulatory submission.
Other devices from General Atomic Co.
Questions
AI-generated answers, 19 Sep 2026
What is the carbon coating on this dental implant designed to do and how does it benefit patients?
The carbon coating on this dental implant is intended to enhance biocompatibility, meaning it reduces the risk of adverse reactions when placed in the body. This coating also promotes better osseointegration—where the bone naturally grows and bonds to the implant—creating a more stable foundation for dental prosthetics. This can improve long-term success rates and patient comfort compared to uncoated implants.
Is this implant meant for use in specific types of dental procedures, or can it be used broadly for any dental restoration?
This implant is designed for osseointegration within the alveolar bone to support both fixed and removable dental prosthetics, making it suitable for a broad range of restorative procedures. It is intended for surgical placement by dental professionals in oral and maxillofacial settings, where it can serve as a stable anchor for crowns, bridges, or dentures.
How is this implant supplied, and what should clinicians know about its sterility and single-use nature?
The implant is supplied as a sterile, single-use device, meaning each unit is intended for one surgical procedure only. Clinicians should handle it with sterile techniques to maintain its sterility until implantation. Since it is single-use, any unused portion must be discarded according to standard medical device disposal protocols to avoid contamination or reuse risks.
What regulatory pathway was followed for this device, and how does that affect its use in clinical settings?
This implant was cleared through the FDA’s 510(k) process (K772304) under the classification of a Class II medical device, with a decision code indicating it is substantially equivalent to a predicate device. This means it has undergone review by the FDA’s Dental Advisory Committee (DE) and meets established safety and effectiveness standards for dental implants. Clinicians can rely on this clearance as evidence of its regulatory compliance for use in oral and maxillofacial surgeries.