A-dec 551sta
by A-Dec, Inc.
A-dec 551sta is a Class I device made by A-Dec, Inc., cleared under FDA 510(k) K213932 on 2 Mar 2022 and listed in FDA GUDID since 10 May 2023 (UDI-DI 10194665005429), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10194665005429 | Date10 May 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213932 | Date2 Mar 2022 | StatusActive |
Official records
- AccessGUDID record 10194665005429
- FDA 510(k) database K213932
Across registries
- FDA 510(k) K213932 decided 2 Mar 2022 Active
- FDA GUDID UDI-DI 10194665005429 listed 10 May 2023 Listed
Timeline
- Cleared FDA 510(k) K213932
- Listed FDA GUDID 10194665005429
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- A-dec
- Generic name
- Dental delivery system
- Model / Ref / Catalog
- 551sta
- Primary DI / UDI-DI
- 10194665005429
- 510(k) Number
- FDA product code
- EIA
- GMDN term
- Dental delivery system
- Device class
- Class I
- Regulation number
- 872.6640
- GUDID distribution status
- In Commercial Distribution
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