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Waterpik Original Tofflemire Matrix Bands
EUDAMEDFDA UDIClass I (EU MDR)
Ref 34579-7
Identity
- Trade Name
- Waterpik Original Tofflemire Matrix Bands EUDAMEDFDA UDI
- Generic Name
- Dental matrix band, single-use FDA UDI
- Device Name
- Dental Matrix Bands EUDAMEDNo. 2 Adult MOD Wide FDA UDI
- Model / Reference
- 34579-7 EUDAMEDFDA UDI
- Description
- No. 2 Adult MOD Wide FDA UDI
Identifiers
- Catalog Number
- 34579-7 FDA UDI
- Primary DI / UDI-DI
- D6863457973 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D68638786NR EUDAMED
- Unit of Use DI
- D6863457970 EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
- GMDN Term
- Dental matrix band, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not 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
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Depth — 0.002 Inch FDA UDI
Waterpik Original Tofflemire Matrix Bands 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 | ++D68638786NR | 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 10b45526-45ea-4b0a-a87e-508c5b4902d2 61 fields · synced Jul 25, 2026
- FDA UDI 73a472a3-ec93-430a-89b7-7a982b793f5b 37 fields · synced May 30, 2026