Identity
- Trade Name
- ProTech UBAR FDA UDI
- Generic Name
- Denture reliner, elastic, short-term FDA UDI
- Device Name
- ProTech UBAR Powder Only 160 g Shade 1069LO FDA UDI
- Model / Reference
- UBARV11GA FDA UDI
- Description
- ProTech UBAR Powder Only 160 g Shade 1069LO FDA UDI
Identifiers
- Catalog Number
- UBARV11GA FDA UDI
- Primary DI / UDI-DI
- D814UBARV11GA0 FDA UDI
- 510(k) Number
- K131036 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
- 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Denture reliner, elastic, short-term
ProTech UBAR by Protech Professional Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Denture reliner, elastic, short-term.
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- Henry Schein — HENRY SCHEIN, INC. · Class II
- GC Reline ™ — Gc America Inc. · Class II
- Sofreliner Tough — TOKUYAMA DENTAL CORPORATION · Class II
- COE-COMFORT™ — Gc America Inc. · Class II
- COE-COMFORT™ — Gc America Inc. · Class II
- COE-COMFORT™ — Gc America Inc. · Class II
- GC Reline ™ — Gc America Inc. · Class II
Cleared under the same submission
K131036 also covers:
- D814UBAR87D0 — PROTECH PROFESSIONAL PRODUCTS, INC.
- ProTech Plus Hard Reline and Repair Acrylic — PROTECH PROFESSIONAL PRODUCTS, INC.
- ProTech Plus Hard Reline and Repair Acrylic — PROTECH PROFESSIONAL PRODUCTS, INC.
- ProTech Plus Hard Reline and Repair Acrylic — PROTECH PROFESSIONAL PRODUCTS, INC.
- ProTech Plus Hard Reline and Repair Acrylic — PROTECH PROFESSIONAL PRODUCTS, INC.
- ProTech Plus Hard Reline and Repair Acrylic — PROTECH PROFESSIONAL PRODUCTS, INC.
- ProTech Plus Hard Reline and Repair Acrylic — PROTECH PROFESSIONAL PRODUCTS, INC.
- ProTech UBAR — PROTECH PROFESSIONAL PRODUCTS, INC.
- ProTech UBAR — PROTECH PROFESSIONAL PRODUCTS, INC.
- ProTech UBAR — PROTECH PROFESSIONAL PRODUCTS, INC.
- ProTech UBAR — PROTECH PROFESSIONAL PRODUCTS, INC.
- ProTech UBAR — PROTECH PROFESSIONAL PRODUCTS, INC.
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 75ba8d2f-8f63-4a3b-8058-4b6b4d0ff620 35 fields · synced Jun 1, 2026