Etchmaster
EtchMaster® disposable Small microetching tip prefilled with 50% Alum Oxide and 50% Sodium Bi-Carbonate (Color code marking BLUE) with Regular bend nozzle.
1manufacturer
18catalogue numbers in this listing
1510(k) clearance
1recall
Who Else Makes It
Registered in Guangxi.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
Record
| Listed by | Groman Inc., United States |
|---|---|
| FDA product code | KOJ |
| Device type | Airbrush |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6080 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K030292 |
| Record published | 2016-09-27 |
| Record revised | 2026-07-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 25, bag of 2, box of 50, box of 16, box of 100, box of 32 |
| Distribution end date | 2026-08-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EM-L-K-CA | In distribution | |
| EM-S-K-RB | In distribution | |
| EM-S-O-RB | In distribution | |
| EM-S-B-RB | In distribution | |
| EM-S-R-RB | In distribution | |
| EM-L-K-RB | In distribution | |
| EM-L-R-RB | In distribution | |
| EM-S-P-RB | In distribution | |
| EM-S-K-CA | In distribution | |
| EM-S-Y-RB | In distribution | |
| EM-L-F-RB | In distribution | |
| EM-L-N-RB | In distribution | |
| EM-S-G-RB | In distribution | |
| EM-L-G-RB | In distribution | |
| EM-S-J-RB | In distribution | |
| EM-L-Y-RB | In distribution | |
| PM-X-L-RB | In distribution | |
| EM-L-B-RB | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AIR-Flow | E.M.S. Electro Medical Systems S.A. | 21 |
| Etchmaster | Reliance Orthodontic Products, Inc. | 21 |
| Johnson-Promident | Young Innovations Inc. | 11 |
| Jetpolisher 2000 | Deldent, Ltd. | 10 |
| HuFriedyGroup | HU-Friedy MFG Co., LLC | 8 |
| Microetcher | Danville Materials, LLC | 7 |
| Henry Schein | Henry Schein, Inc. | 7 |
| AIR-Flow-Piezon | E.M.S. Electro Medical Systems S.A. | 5 |
| PWR Handpiece | HU-Friedy MFG Co., LLC | 3 |
| CoJet™ Prep | 3M Deutschland GmbH | 2 |
| JP/JST/JS Handpiece | Deldent, Ltd. | 2 |
| GBT Machine Wireless Pedal | E.M.S. Electro Medical Systems S.A. | 2 |
Showing 12 of 48. All products under Airbrush
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K030292 | 2003-04-15 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-12-13 | Not classified | Nonconforming Material/Component | Groman Inc. of Margate, FL recalled their product Cordless Etcher Air Brush. When non-conforming cartridges are inserted into the Cordless Etcher they can induce excessive stresses on the device causing cracks in the plastic housing of the | 395 | 2012-01-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.