Identity
- Trade Name
- ProTech Soft Reline FDA UDI
- Generic Name
- Denture reliner, elastic, short-term FDA UDI
- Device Name
- 8 unit ProTech Soft Reline Self Cure Kit Shade Clear - 110 gram powder, 60 ml monomer, 15 ml superbond FDA UDI
- Model / Reference
- SRC11C FDA UDI
- Description
- 8 unit ProTech Soft Reline Self Cure Kit Shade Clear - 110 gram powder, 60 ml monomer, 15 ml superbond FDA UDI
Identifiers
- Catalog Number
- SRC11C FDA UDI
- Primary DI / UDI-DI
- D814SRC11C1 FDA UDI
- 510(k) Number
- K151646 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Denture reliner, elastic, short-term FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 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
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
ProTech Soft Reline by Protech Professional Products, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Protech Professional Products, Inc.
Sources (1)
- FDA UDI 4087af8b-bfad-4394-a701-600d32dfb7f2 36 fields · synced May 30, 2026