3I Innovative Implants and Cover Screws
by Implant Innovations, Inc. 510(k)
Active
510(k) K972444
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK972444 | Date26 Aug 1997 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-2521-2016
- Terminated Z-2500-2016
Pouches may not have been sealed during packing.
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, 1 Oct 2026
The 3I Innovative Implants and Cover Screws are endosseous dental implants designed for osseointegration in the jawbone. These implants feature an internally tapered Morse taper with an interlocking hex connection, enabling secure fixation and facilitating a one-stage surgical protocol. They are placed at or below the mucosal tissue surface and include cover screws for the healing abutment phase. The product is classified under FDA product code DZE for dental implants.
These implants are intended for use in dental surgery by clinicians to restore oral function and aesthetics. Supplied sterile for single-use, they require no additional sterilisation and are regulated under FDA 510(k) clearance (K972444) as substantially equivalent to a predicate device. The device is manufactured by Implant Innovations, Inc., and adheres to dental implant standards for osseointegration and mucosal integration. Storage and handling follow standard sterile medical device protocols.