Identity
- Trade Name
- EtchArrest FDA UDI
- Generic Name
- Dental repair kit, ceramic FDA UDI
- Device Name
- EtchArrest Kit FDA UDI
- Model / Reference
- 625 FDA UDI
- Description
- EtchArrest Kit FDA UDI
Identifiers
- Catalog Number
- 625 FDA UDI
- Primary DI / UDI-DI
- 00883205103710 FDA UDI
- FDA Product Code
- EIH FDA UDI
- GMDN Term
- Dental repair kit, ceramic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6660 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
Yes
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
No
FDA UDI
Category: Dental repair kit, ceramic
EtchArrest by Ultradent Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental repair kit, ceramic.
- Interface A Bottle — Vista Dental · Class II
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- GC CERAMIC PRIMER II — Gc America Inc. · Class II
- FUSION Silane — Taub Products · Class II
- ReVeneer Composite Filli — Schütz Dental GmbH · Class II
- Etching Gel Kit — Cosmedent, Inc.
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
- Ultradent Products, Inc.
Sources (1)
- FDA UDI d06f04c1-fb3f-4c5f-ba6d-90828b111327 36 fields · synced May 30, 2026