Identity
- Trade Name
- Etching Gel Kit FDA UDI
- Generic Name
- Dental repair kit, ceramic FDA UDI
- Device Name
- Etching Gel Kit includes 1 syringe Dentin/EnamelETCH, 1 syringe PorcelETCH (green), 2 syringes PorcelETCH (clear), 1 GINGA-Guard (3 g) syringe, 1 Silanator (10 ml) bottle plus 25 tips (25 gauge). FDA UDI
- Model / Reference
- 663005 FDA UDI
- Description
- Etching Gel Kit includes 1 syringe Dentin/EnamelETCH, 1 syringe PorcelETCH (green), 2 syringes PorcelETCH (clear), 1 GINGA-Guard (3 g) syringe, 1 Silanator (10 ml) bottle plus 25 tips (25 gauge). FDA UDI
Identifiers
- Catalog Number
- 663005 FDA UDI
- Primary DI / UDI-DI
- D7796630053 FDA UDI
- GMDN Term
- Dental repair kit, ceramic FDA UDI
Classification
- 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
Etching Gel Kit by Cosmedent, Inc. — 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
- EMBRACE WETBOND RESTORATION & PFM REPAIR KIT — Pulpdent Corporation · Class II
- ReVeneer Adhesive Set — Schütz Dental GmbH · Class II
- K-Primer — bredent GmbH & Co. KG · Class II
- GC CERAMIC PRIMER II — Gc America Inc. · Class II
- FUSION Silane — Taub Products · Class II
- ReVeneer Composite Filli — Schütz Dental GmbH · Class II
- EtchArrest — ULTRADENT PRODUCTS, INC. · Class II
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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cosmedent, Inc.
Sources (1)
- FDA UDI f57b3f53-4482-4789-ad89-58f5aa391db8 34 fields · synced May 30, 2026