Identity
- Trade Name
- DTK adhesive assortment FDA UDI
- Generic Name
- Dental repair kit, ceramic FDA UDI
- Device Name
- DTK adhesive assortment in a double mixing cartridge 5 Parts FDA UDI
- Model / Reference
- 54001185 FDA UDI
- Description
- DTK adhesive assortment in a double mixing cartridge 5 Parts FDA UDI
Identifiers
- Catalog Number
- 54001185 FDA UDI
- Primary DI / UDI-DI
- EBRE540011850 FDA UDI
- FDA Product Code
- KOL FDA UDI
- GMDN Term
- Dental repair kit, ceramic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3410 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
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
Yes
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
DTK adhesive assortment by bredent GmbH & Co. KG — Class I — 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
- 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
- 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- bredent GmbH & Co. KG
Sources (1)
- FDA UDI 1daf33a9-4a6d-4d17-bf9d-e85357041b60 35 fields · synced Jun 1, 2026