Identity
- Trade Name
- Bosworth Fastray LC FDA UDI
- Generic Name
- Dental impression tray material FDA UDI
- Device Name
- Fastray LC Standard Kit Blue FDA UDI
- Model / Reference
- 0921405 FDA UDI
- Description
- Fastray LC Standard Kit Blue FDA UDI
Identifiers
- Catalog Number
- 0921405 FDA UDI
- Primary DI / UDI-DI
- H66809214051 FDA UDI
- 510(k) Number
- K991631 FDA UDI
- FDA Product Code
- ELW FDA UDI
- GMDN Term
- Dental impression tray 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
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: Dental impression tray material
Bosworth Fastray LC by Harry J. Bosworth Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental impression tray material.
- Eazipan LC — VERICOM CO., LTD. · Class I
- INSTANT TRAY MIX POWDER — Lang Dental Manufacturing Company, Inc. · Class I
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- Premium Tray — Denplus Inc · Class I
- OpaTray — OPA DENTAL, LLC · Class I
- DURALAY - BLUE — Reliance Dental Manufacturing · Class I
- SR Ivolen — IVOCLAR VIVADENT AKTIENGESELLSCHAFT · Class I
- JET TRAY POWDER — Lang Dental Manufacturing Company, Inc. · Class I
Cleared under the same submission
K991631 also covers:
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 e9f04742-4f9d-4010-9106-ec6e0d2e1bdd 37 fields · synced Jun 8, 2026