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Waterpik Kelly's Z.O.E. Impression Paste
EUDAMEDClass I (EU MDR)
Ref 011350-000
Identity
- Trade Name
- Waterpik Kelly's Z.O.E. Impression Paste EUDAMED
- Device Name
- Dental Impression Paste EUDAMED
- Model / Reference
- 011350-000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D6860113503 EUDAMED
- Basic UDI-DI
- ++D68617844MH EUDAMED
- EMDN Code
- Q01020199 DENTAL IMPRESSION MATERIALS - OTHER EUDAMED
Classification
- Device Class
- Class I 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: Silicone dental impression material
Waterpik Kelly's Z.O.E. Impression Paste by Water Pik, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Silicone dental impression material.
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- PERFECTO — CROWN DELTA CORP. · Class II
- Bona-Bite 50ml x 32 — DMP Dental Industry S.A. · Class I
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 | ++D68617844MH | Class I | Active |
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Manufacturer
- Manufacturer
- Water Pik, Inc.
- EUDAMED SRN
- US-MF-000017734
- Authorised Representative
- Sofibel FR-AR-000003191
Sources (1)
- EUDAMED 9bc20e62-c97a-4a1a-afa3-6aa6f4eb3233 61 fields · synced Jun 18, 2026