Identity
- Trade Name
- Bosworth Sapphire FDA UDI
- Generic Name
- Composite dental impression material FDA UDI
- Device Name
- PEMA P&L Acrylic Impression Material Kit, Blue FDA UDI
- Model / Reference
- 0921740 FDA UDI
- Description
- PEMA P&L Acrylic Impression Material Kit, Blue FDA UDI
Identifiers
- Catalog Number
- 0921740 FDA UDI
- Primary DI / UDI-DI
- H66809217401 FDA UDI
- FDA Product Code
- ELW FDA UDI
- GMDN Term
- Composite dental impression material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3660 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: Composite dental impression material
Bosworth Sapphire by Harry J. Bosworth Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Composite dental impression material.
- Accusil Heavy Body — PREVEST DENPRO LIMITED · Class II
- Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class II
- Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class II
- UltraSil Putty 1000 — Dsi Dental Solutions, Ltd. · Class II
- Accusil Monophase — PREVEST DENPRO LIMITED · Class II
- Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class II
- Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class II
- Patterson® — PATTERSON DENTAL SUPPLY, INC. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Harry J. Bosworth Co.
Sources (1)
- FDA UDI b3182d3d-4adb-449b-b1b9-16817f47c78e 36 fields · synced May 30, 2026