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HySolate Dental Dam Frame Plastic U-Shaped Child (5 x 5), 1 pc
EUDAMEDFDA UDIClass I (EU MDR)
Ref H01416
by Dent4You AG
Identity
- Trade Name
- HySolate Dental Dam Frame Plastic U-Shaped Child (5 x 5), 1 pc EUDAMEDHysolate FDA UDI
- Generic Name
- Rubber dam frame FDA UDI
- Device Name
- HySolate Dental Dam Frames EUDAMEDDental Dam Frame plastic U-Shaped Child (5 x 5), 1 pc FDA UDI
- Model / Reference
- H01416 EUDAMEDFDA UDI
- Description
- Dental Dam Frame plastic U-Shaped Child (5 x 5), 1 pc FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630392900423 EUDAMEDFDA UDI
- Basic UDI-DI
- 76303929DDFRAMENH EUDAMED
- FDA Product Code
- EJE FDA UDI
- EMDN Code
- Q019002 DENTISTRY DAMS AND HOOKS, SINGLE-USE EUDAMED
- GMDN Term
- Rubber dam frame FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
HySolate Dental Dam Frame Plastic U-Shaped Child (5 x 5), 1 pc by Dent4You AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 76303929DDFRAMENH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dent4You AG
- EUDAMED SRN
- CH-MF-000028926
- Authorised Representative
- Coltène/Whaledent GmbH + Co. KG DE-AR-000005719
Sources (2)
- EUDAMED 26bce7be-1836-4256-991b-f86219925f94 61 fields · synced Jun 18, 2026
- FDA UDI e4d25d5c-bfc6-42da-a60e-99213d3ced95 33 fields · synced May 30, 2026