Identity
- Trade Name
- Hysolate FDA UDI
- Generic Name
- Rubber dam clamp FDA UDI
- Device Name
- HySolate Fiesta Dental Dam Clamp Organizer , 1 pc FDA UDI
- Model / Reference
- H09956 FDA UDI
- Description
- HySolate Fiesta Dental Dam Clamp Organizer , 1 pc FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630392900911 FDA UDI
- FDA Product Code
- EEF FDA UDI
- GMDN Term
- Rubber dam clamp FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6300 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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 by Dent4You AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dent4You AG
Sources (1)
- FDA UDI 2984db31-a604-4af5-b26e-abdd24eac71b 34 fields · synced May 30, 2026