Etchmaster EM-S-K-RB
by Groman Inc.
Etchmaster EM-S-K-RB, 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 19 Sep 2016 (UDI-DI 00817494020021); 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 | Number00817494020021 | Date19 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK030292 | Date15 Apr 2003 | StatusActive |
Official records
- AccessGUDID record 00817494020021
- FDA 510(k) database K030292
Across registries
- FDA 510(k) K030292 decided 15 Apr 2003 Active
- FDA GUDID UDI-DI 00817494020021 listed 19 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K030292
- Listed FDA GUDID 00817494020021
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- Withdrawn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-RB
- Primary DI / UDI-DI
- 00817494020021
- 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
Similar devices
Other devices filed under FDA product code KOJ (Airbrush).
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- KREATIV MODEL KV-1 by Kreativ, Inc.
- VELOPEX AQUACUT FLUID ABRASION UNIT by VELOPEX INTERNATIONAL, INC.
- SCHEIN AP-1 AIR POLISHING UNIT by HENRY SCHEIN, INC.
- SANDBLASTER by Mirage Dental Systems
- SIMPLEX AIRBRATOR (SAB-7) by Irt Management Corp.
- turbodent touch by Mectron S.p.A.
- ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-1 by Crystal Mark, Inc.
- JETPOLISHER(TM) by YOUNG DENTAL MANUFACTURING CO 1, LLC.