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ALPHA-ETCH37 ETCHANT GEL DARK BLUE 37% PHOSPHORIC ACID 4 x 1.2ml SYRINGE KIT
EUDAMEDClass IIa (EU MDR)
Ref 501-1213-002
Identity
- Trade Name
- ALPHA-ETCH37 ETCHANT GEL DARK BLUE 37% PHOSPHORIC ACID 4 x 1.2ml SYRINGE KIT EUDAMED
- Device Name
- Etchant EUDAMED
- Model / Reference
- 501-1213-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D73550112130020 EUDAMED
- Basic UDI-DI
- ++D735Etchant32 EUDAMED
- EMDN Code
- Q01010402 ENAMEL-DENTINAL ETCHING MATERIALS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Dental etching solution
ALPHA-ETCH37 ETCHANT GEL DARK BLUE 37% PHOSPHORIC ACID 4 x 1.2ml SYRINGE KIT by Dental Technologies, Inc. — Class IIa — MDR — listed in EUDAMED
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 (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++D735Etchant32 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dental Technologies, Inc.
- EUDAMED SRN
- US-MF-000027130
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED fcb4c578-6fb8-42cd-a63a-13d55fa6207b 61 fields · synced Jun 18, 2026