Identity
- Trade Name
- Waterpik Opotow Trial Cement EUDAMEDFDA UDI
- Generic Name
- Zinc oxide eugenol dental cement FDA UDI
- Device Name
- Zinc Oxide Eugenol Dental Cement EUDAMEDNon-hardening zinc oxide eugenol temporary dental cement FDA UDI
- Model / Reference
- 052120-000 EUDAMEDFDA UDI
- Description
- Non-hardening zinc oxide eugenol temporary dental cement FDA UDI
Identifiers
- Catalog Number
- 052120-000 FDA UDI
- Primary DI / UDI-DI
- D686521203 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D68662200LK EUDAMED
- FDA Product Code
- EMB FDA UDI
- EMDN Code
- Q0101010203 TEMPORARY DENTAL CEMENTS EUDAMED
- GMDN Term
- Zinc oxide eugenol dental cement FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3275 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 10 Gram FDA UDIWeight — 38 Gram FDA UDI
Waterpik Opotow Trial Cement by Water Pik, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | ++D68662200LK | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Water Pik, Inc.
- EUDAMED SRN
- US-MF-000017734
- Authorised Representative
- Sofibel FR-AR-000003191
Sources (2)
- EUDAMED acffcb81-972d-4076-935b-927637c5344d 61 fields · synced Jul 10, 2026
- FDA UDI 63b4ae1b-a582-4dbc-840f-9f0f407d0e7a 38 fields · synced May 30, 2026