Identity
- Trade Name
- ProTech Plus Hard Reline and Repair Acrylic FDA UDI
- Generic Name
- Denture reliner, elastic, short-term FDA UDI
- Device Name
- 2.25 kg ProTech Plus Hard Reline and Repair Acrylic Shade JP FDA UDI
- Model / Reference
- PLU13G FDA UDI
- Description
- 2.25 kg ProTech Plus Hard Reline and Repair Acrylic Shade JP FDA UDI
Identifiers
- Catalog Number
- PLU13G FDA UDI
- Primary DI / UDI-DI
- D814PLU13G1 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
No
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
No
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 1c602365-ac61-46cb-9ff5-678c56c373bd 36 fields · synced Jun 1, 2026