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HYGENIC Orthodontic Tray Wax, White, 48 pcs
EUDAMEDFDA UDIClass I (EU MDR)
Ref H00827
Identity
- Trade Name
- HYGENIC Orthodontic Tray Wax, White, 48 pcs EUDAMEDHygenic FDA UDI
- Generic Name
- Dental base plate FDA UDI
- Device Name
- HYGENIC Waxes EUDAMEDOrthodontic Tray Wax Strips FDA UDI
- Model / Reference
- H00827 EUDAMEDFDA UDI
- Description
- Orthodontic Tray Wax Strips FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661H008271 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D661039KU EUDAMED
- FDA Product Code
- EGD FDA UDI
- EMDN Code
- Q01020203 OCCLUSAL WAXES EUDAMED
- GMDN Term
- Dental base plate FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6890 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
HYGENIC Orthodontic Tray Wax, White, 48 pcs by Coltene/Whaledent 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 | ++D661039KU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Coltene/Whaledent Inc.
- EUDAMED SRN
- US-MF-000015761
- Authorised Representative
- Coltène/Whaledent GmbH + Co. KG DE-AR-000005719
Sources (2)
- EUDAMED 50bfe302-ac1a-489f-9108-f95e2b95bf19 61 fields · synced Jun 19, 2026
- FDA UDI bf9bb230-295d-4f99-b40f-68687db94624 34 fields · synced May 30, 2026