Identity
- Trade Name
- Etchmaster FDA UDI
- Generic Name
- Dental abrasive air jet system FDA UDI
- Device Name
- The Etchmaster system is intended for use as a microetcher of a surface prior to bonding with an orthodontic adhesive. This is the Handpiece for connection to an airline. FDA UDI
- Model / Reference
- EMHAR FDA UDI
- Description
- The Etchmaster system is intended for use as a microetcher of a surface prior to bonding with an orthodontic adhesive. This is the Handpiece for connection to an airline. FDA UDI
Identifiers
- Catalog Number
- EMHAR FDA UDI
- Primary DI / UDI-DI
- D798EMHAR0 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental abrasive air jet system
Etchmaster by Reliance Orthodontic Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental abrasive air jet system.
- AIR-FLOW — E.M.S. Electro Medical Systems S.A. · Class I
- AIR-FLOW — E.M.S. Electro Medical Systems S.A. · Class I
- AIR-FLOW-PIEZON — E.M.S. Electro Medical Systems S.A. · Class II
- AIR-FLOW — E.M.S. Electro Medical Systems S.A. · Class II
- AIR-FLOW — E.M.S. Electro Medical Systems S.A. · Class I
- Cavitron® — Dentsply Professional · Class II
- AIR-FLOW-PIEZON — E.M.S. Electro Medical Systems S.A. · Class II
- JETPOLISHER 2000 — DELDENT LTD. · Class II
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
- Reliance Orthodontic Products, Inc.
Sources (1)
- FDA UDI 10a7da28-a1b4-48c7-adfe-e80dc5e0ab7e 36 fields · synced Jun 1, 2026