Identity
- Trade Name
- ProTech Plus Hard Reline and Repair Acrylic FDA UDI
- Generic Name
- Denture reliner, elastic, short-term FDA UDI
- Device Name
- ProTech Plus Hard Reline and Repair Acrylic Kit - 440 gram powder shade 1069LO and 240 ml Monomer FDA UDI
- Model / Reference
- PLU12A FDA UDI
- Description
- ProTech Plus Hard Reline and Repair Acrylic Kit - 440 gram powder shade 1069LO and 240 ml Monomer FDA UDI
Identifiers
- Catalog Number
- PLU12A FDA UDI
- Primary DI / UDI-DI
- D814PLU12A1 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 Plus Hard Reline and Repair Acrylic 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 50af9828-d1c4-4557-b05a-4f03fa0eee7d 36 fields · synced May 31, 2026