Identity
- Trade Name
- Waterpik Soft Shine Prophy Paste EUDAMEDFDA UDI
- Generic Name
- Dentifrice FDA UDI
- Device Name
- Dental Polishing Paste EUDAMEDMint flavor, ultra-fine grit FDA UDI
- Model / Reference
- 20008940 EUDAMEDFDA UDI
- Description
- Mint flavor, ultra-fine grit FDA UDI
Identifiers
- Catalog Number
- 20008940 FDA UDI
- Primary DI / UDI-DI
- D686200089403 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D68611168KJ EUDAMED
- Unit of Use DI
- D686200089400 EUDAMED
- FDA Product Code
- EJR FDA UDI
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMED
- GMDN Term
- Dentifrice FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6030 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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 — 2 Gram FDA UDI
Waterpik Soft Shine Prophy Paste 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 | ++D68611168KJ | 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 cd4af057-f7ac-4ce6-afd8-bc10e52965bc 61 fields · synced Jun 18, 2026
- FDA UDI bb52efd4-eb31-4783-9f36-cba8b82cf8da 37 fields · synced May 30, 2026