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Etchmaster EM-S-B-RB

by Groman Inc.

Etchmaster EM-S-B-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 27 Sep 2016 (UDI-DI 00817494020076); the registry lists it as not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K030292

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817494020076 UDI-DI Date27 Sep 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK030292 Date15 Apr 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K030292 decided 15 Apr 2003 Active
  • FDA GUDID UDI-DI 00817494020076 listed 27 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K030292
  2. Listed FDA GUDID 00817494020076

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Etchmaster
Generic name
Chairside dental abrasive air jet system
Model / Ref / Catalog
EM-S-B-RB
Primary DI / UDI-DI
00817494020076
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

Related devices

Category: Dental abrasive air jet system

Cleared under the same submission (K030292)

and 8 more cleared under K030292

Similar devices

Other devices filed under FDA product code KOJ (Airbrush).

Other devices from Groman Inc.

Properties

  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)