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Sylc Bioactive Dental Powder (Green label)
EUDAMEDClass IIa (EU MDR)
Ref I/PDR 0034F
Identity
- Trade Name
- Sylc Bioactive Dental Powder (Green label) EUDAMED
- Device Name
- Dental Air Abrasion Powder EUDAMED
- Model / Reference
- I/PDR 0034F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 50602095801736 EUDAMED
- Basic UDI-DI
- 506020958ACPowdersA9 EUDAMED
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING 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
Sylc Bioactive Dental Powder (Green label) by Medivance Instruments Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 506020958ACPowdersA9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medivance Instruments Limited
- EUDAMED SRN
- GB-MF-000024293
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED fcf6f70c-bc4d-4801-a354-e8f298e355c6 61 fields · synced Sep 18, 2026