Etchmaster EM-S-K-CA
by Groman Inc.
Etchmaster EM-S-K-CA, a chairside dental abrasive air jet system (FDA Class II; FDA product code KOJ, Airbrush) made by Groman Inc., was cleared under FDA 510(k) K030292 on 15 Apr 2003 and listed in FDA GUDID on 27 Sep 2016 (UDI-DI 00817494020038); the registry lists it as not in commercial distribution (GUDID) as of 22 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 | Number00817494020038 | Date27 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK030292 | Date15 Apr 2003 | StatusActive |
Official records
- AccessGUDID record 00817494020038
- FDA 510(k) database K030292
Across registries
- FDA 510(k) K030292 decided 15 Apr 2003 Active
- FDA GUDID UDI-DI 00817494020038 listed 27 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K030292
- Listed FDA GUDID 00817494020038
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Etchmaster
- Generic name
- Chairside dental abrasive air jet system
- Model / Ref / Catalog
- EM-S-K-CA
- Primary DI / UDI-DI
- 00817494020038
- 510(k) Number
- FDA product code
- KOJ
- GMDN term
- Chairside dental abrasive air jet system
- Device class
- Class II
- Regulation number
- 872.6080
- GUDID distribution status
- Not in Commercial Distribution
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