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Waterpik Original Tofflemire II Matrix Band Retainer
EUDAMEDFDA UDIClass I (EU MDR)
Ref 20016455
Identity
- Trade Name
- Waterpik Original Tofflemire II Matrix Band Retainer EUDAMEDFDA UDI
- Generic Name
- Dental matrix band retainer FDA UDI
- Device Name
- Dental Matrix Retainer EUDAMEDContra-Angle FDA UDI
- Model / Reference
- 20016455 EUDAMEDFDA UDI
- Description
- Contra-Angle FDA UDI
Identifiers
- Catalog Number
- 20016455 FDA UDI
- Primary DI / UDI-DI
- D6860611020003 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D68633204KZ EUDAMED
- FDA Product Code
- JEP FDA UDI
- EMDN Code
- L15901101 POSITIONING INSTRUMENTS FOR DENTAL MATRICES, REUSABLE EUDAMED
- GMDN Term
- Dental matrix band retainer 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
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
Moist Heat or Steam Sterilization FDA UDI
Waterpik Original Tofflemire II Matrix Band Retainer 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 | ++D68633204KZ | 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 d3fbfea2-d1d4-486b-8f81-90fd34231d39 61 fields · synced Jul 10, 2026
- FDA UDI 703de970-0d57-432f-b35d-8782c12e6960 36 fields · synced May 30, 2026