Identity
- Trade Name
- TEMPO FDA UDI
- Generic Name
- Denture reliner, soft, professional FDA UDI
- Device Name
- CUSHION TREATMENT DENTURE REPAIR RELINE ACRYLIC RESIN POWDER AND LIQUID FDA UDI
- Model / Reference
- POUND PACKAGE WHITE FDA UDI
- Description
- CUSHION TREATMENT DENTURE REPAIR RELINE ACRYLIC RESIN POWDER AND LIQUID FDA UDI
Identifiers
- Catalog Number
- 1034WHT FDA UDI
- Primary DI / UDI-DI
- D6501034WHT0 FDA UDI
- 510(k) Number
- K081514 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Denture reliner, soft, professional 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Category: Denture reliner, soft, professional
Tempo by Lang Dental Manufacturing Company, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Denture reliner, soft, professional.
- Axcent Acrylics — GARRECO, LLC · Class II
- Lynal® Tissue Conditioner and Temporary Reliner — Dentsply International · Class II
- Bosworth Trusoft — Harry J. Bosworth Co. · Class II
- EasySoft Liner Starter Kit — Karlin Dental Distributors Inc · Class II
- Silk Line Refill Cartridge — J. MORITA U.S.A., INC · Class II
- Hydro-Cast® — Sultan Healthcare Inc · Class II
- SUPER-SOFT™ — Gc America Inc. · Class II
- Chairside — Zest Anchors, LLC · Class II
Cleared under the same submission
K081514 also covers:
- TEMPO — Lang Dental Manufacturing Company, Inc.
- TEMPO — Lang Dental Manufacturing Company, Inc.
- TEMPO — Lang Dental Manufacturing Company, Inc.
- TEMPO — Lang Dental Manufacturing Company, Inc.
- TEMPO — Lang Dental Manufacturing Company, Inc.
- TEMPO — Lang Dental Manufacturing Company, Inc.
- TEMPO — Lang Dental Manufacturing Company, Inc.
- TEMPO — Lang Dental Manufacturing Company, Inc.
- TEMPO — Lang Dental Manufacturing Company, Inc.
- TEMPO — Lang Dental Manufacturing Company, Inc.
- TEMPO LIQUID — Lang Dental Manufacturing Company, Inc.
- TEMPO LIQUID — Lang Dental Manufacturing Company, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lang Dental Manufacturing Company, Inc.
Sources (1)
- FDA UDI c9cebb63-8201-40f4-aecf-d55759391db4 35 fields · synced Jun 8, 2026