Identity
- Trade Name
- Hysolate FDA UDI
- Generic Name
- Rubber dam clamp FDA UDI
- Device Name
- Winged Complete Kit Non-latex Premium Instruments FDA UDI
- Model / Reference
- 60019066 FDA UDI
- Description
- Winged Complete Kit Non-latex Premium Instruments FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630392901116 FDA UDI
- FDA Product Code
- EEF FDA UDIEIE FDA UDIEJG FDA UDIEJB FDA UDI
- GMDN Term
- Rubber dam clamp FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6300 FDA UDI872.4565 FDA UDI
- Commercial Distribution
- 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
Yes
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
Category: Rubber dam clampRubber dam, non-latexRubber dam clamp forcepsRubber dam punch
Hysolate by Dent4You AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Rubber dam punch.
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- Pomee — POMEE CORPORATION · Class I
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 c0bfee1f-f7fd-4837-b7d1-6be2811e9d39 33 fields · synced Jun 6, 2026