ARENA Star Arum-DR-12-D4
ARENA Star Arum-DR-12-D4 is a Class II device made by ARUM DENTISTRY Co., Ltd., cleared under FDA 510(k) K223253 on 27 Feb 2023 and listed in FDA GUDID since 4 Apr 2023 (UDI-DI 08800055736471), 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 | Number08800055736471 | Date4 Apr 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK223253 | Date27 Feb 2023 | StatusActive |
Official records
- AccessGUDID record 08800055736471
- FDA 510(k) database K223253
Across registries
- FDA 510(k) K223253 decided 27 Feb 2023 Active
- FDA GUDID UDI-DI 08800055736471 listed 4 Apr 2023 Listed
Timeline
- Cleared FDA 510(k) K223253
- Listed FDA GUDID 08800055736471
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ARENA Star
- Generic name
- Dental appliance fabrication material, ceramic
- Model / reference
- Arum-DR-12-D4
- Primary DI / UDI-DI
- 08800055736471
- 510(k) Number
- FDA product code
- EIH
- GMDN term
- Dental appliance fabrication material, ceramic
- Device class
- Class II
- Regulation number
- 872.6660
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Dental appliance fabrication material, ceramic.