Identity
- Trade Name
- Etchmaster FDA UDI
- Generic Name
- Dental abrasive air jet system FDA UDI
- Device Name
- EtchMaster® disposable Small microetching tip prefilled with 3M Co-Jet (Color code marking BROWN) with Regular bend nozzle. FDA UDI
- Model / Reference
- EM-S-J-RB FDA UDI
- Description
- EtchMaster® disposable Small microetching tip prefilled with 3M Co-Jet (Color code marking BROWN) with Regular bend nozzle. FDA UDI
Identifiers
- Catalog Number
- EM-S-J-RB FDA UDI
- Primary DI / UDI-DI
- 00817494020137 FDA UDI
- 510(k) Number
- K030292 FDA UDI
- FDA Product Code
- KOJ FDA UDI
- GMDN Term
- Dental abrasive air jet system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6080 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental abrasive air jet system
Etchmaster by Groman Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental abrasive air jet system.
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Cleared under the same submission
K030292 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Groman Inc.
Sources (1)
- FDA UDI d0606fcf-7ac8-438a-b832-7fdd0133ad75 37 fields · synced Jun 1, 2026