A-dec 351R
A-dec 351R (351AR) is a Class I device made by A-Dec, Inc., cleared under FDA 510(k) K082985 on 17 Dec 2008 and listed in FDA GUDID since 26 Mar 2024 (UDI-DI 10194665007027), 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 | Number10194665007027 | Date26 Mar 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK082985 | Date17 Dec 2008 | StatusActive |
Official records
- AccessGUDID record 10194665007027
- FDA 510(k) database K082985
Across registries
- FDA 510(k) K082985 decided 17 Dec 2008 Active
- FDA GUDID UDI-DI 10194665007027 listed 26 Mar 2024 Listed
Timeline
- Cleared FDA 510(k) K082985
- Listed FDA GUDID 10194665007027
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- Withdrawn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
- 351R, 351AR
- Primary DI / UDI-DI
- 10194665007027
- 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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