Identity
- Trade Name
- LuxaBond - Total Etch FDA UDI
- Generic Name
- Dental etching solution FDA UDI
- Device Name
- Total Etch dual cure adhesive system. The perfect partner for all direct and indirect techniques. Content: 1 bottle @ 5 ml Pre-Bond, 1 bottle @ 5 ml Bond A, 1 bottle @ 5 ml Bond B, 1 syringe @ 2 ml DMG Etching Gel Medium Viscosity, Accessories. FDA UDI
- Model / Reference
- 212384 FDA UDI
- Description
- Total Etch dual cure adhesive system. The perfect partner for all direct and indirect techniques. Content: 1 bottle @ 5 ml Pre-Bond, 1 bottle @ 5 ml Bond A, 1 bottle @ 5 ml Bond B, 1 syringe @ 2 ml DMG Etching Gel Medium Viscosity, Accessories. FDA UDI
Identifiers
- Catalog Number
- 212384 FDA UDI
- Primary DI / UDI-DI
- EDMG2123841 FDA UDI
- FDA Product Code
- KLE FDA UDI
- GMDN Term
- Dental etching solution FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3200 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dentine bonding agent/setDental etching solution
LuxaBond - Total Etch by DMG Chemisch-Pharmazeutische Fabrik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental etching solution.
- Dento-Etch — Spident · Class IIa
- Vivid TruEtch 10% Kit — PEARSON DENTAL SUPPLIES, INC. · Class II
- DC Keramik Ätzgel — PRISMAN GmbH · Class I
- MASTER-DENT — DENTONICS, INC.
- OSE 8oz. Orthodontic Etching Gel - Blue — ORTHODONTIC SUPPLY & EQUIPMENT CO., INC. · Class II
- ETCHANT — Pulpdent Corporation · Class II
- Scotchbond™ Universal — 3M Deutschland GmbH · Class II
- GC CERAMIC PRIMER II — Gc America Inc. · Class II
Cleared under the same submission
K063444 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DMG Chemisch-Pharmazeutische Fabrik GmbH
Sources (1)
- FDA UDI 6a1c1075-56dc-497c-904a-20bb8f0c1ae5 37 fields · synced May 31, 2026