Identity
- Trade Name
- Bosworth New Truliner FDA UDI
- Generic Name
- Denture reliner, hard FDA UDI
- Device Name
- 8 oz New Truliner PEMA P&L Kit Vein FDA UDI
- Model / Reference
- 0921971 FDA UDI
- Description
- 8 oz New Truliner PEMA P&L Kit Vein FDA UDI
Identifiers
- Catalog Number
- 0921971 FDA UDI
- Primary DI / UDI-DI
- H66809219711 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Denture reliner, hard 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
Yes
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
Yes
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, hard
Bosworth New Truliner by Harry J. Bosworth Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Denture reliner, hard.
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- Sinfony™ — 3M Deutschland GmbH · Class II
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
- Harry J. Bosworth Co.
Sources (1)
- FDA UDI c4a0d829-2824-4f80-a142-d7fe7c0d42e3 36 fields · synced May 31, 2026