Meta G UCLA Abutment
by Cowellmedi Co., Ltd 510(k)
Active
510(k) K232546
Overview
The Meta G UCLA Abutment is a dental device designed to be used with a dental implant. It provides support for prosthetic restorations, including crowns, bridges, or overdentures.
This device has received FDA 510(k) clearance. It is classified as a Class 2 dental device under product code NHA.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK232546 | Date21 Nov 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- NHA
- FDA applicant
- Cowellmedi Co., Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3630
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent