Identity
- Trade Name
- Total Etch Refill 2x2 g EUDAMEDTotal Etch FDA UDI
- Generic Name
- Dental etching solution FDA UDI
- Device Name
- Eco-Etch, N-Etch, Total Etch EUDAMEDTotal Etch Refill 2x2 g FDA UDI
- Model / Reference
- 550588AN EUDAMEDFDA UDI
- Description
- Total Etch Refill 2x2 g FDA UDI
Identifiers
- Catalog Number
- 550588AN FDA UDI
- Primary DI / UDI-DI
- 07615208301472 EUDAMEDFDA UDI
- Basic UDI-DI
- 76152082AETCH001J9 EUDAMED
- Unit of Use DI
- 07615208487800 EUDAMED
- FDA Product Code
- EBF FDA UDI
- EMDN Code
- Q01010402 ENAMEL-DENTINAL ETCHING MATERIALS EUDAMED
- GMDN Term
- Dental etching solution FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Market of Registration
- Liechtenstein EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental etching solution
Total Etch Refill 2x2 g by Ivoclar Vivadent AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental etching solution.
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- ETCHANT — Pulpdent Corporation · Class II
- Scotchbond™ Universal — 3M Deutschland GmbH · Class II
- GC CERAMIC PRIMER II — Gc America Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 76152082AETCH001J9 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Ivoclar Vivadent AG
- EUDAMED SRN
- LI-MF-000000522
Sources (2)
- EUDAMED b1f7f1eb-52bd-478c-a7bd-4393b11b7792 61 fields · synced Jun 18, 2026
- FDA UDI af535e27-b594-41fe-a1e9-198333aa5ec7 34 fields · synced May 30, 2026