Identity
- Trade Name
- Choice 2 Try-In Paste FDA UDI
- Generic Name
- Dental cement trial FDA UDI
- Device Name
- Choice 2 Try-In Paste B1 2g Syringe FDA UDI
- Model / Reference
- C-412B1 FDA UDI
- Description
- Choice 2 Try-In Paste B1 2g Syringe FDA UDI
Identifiers
- Catalog Number
- C-412B1 FDA UDI
- Primary DI / UDI-DI
- D757C412B10 FDA UDI
- 510(k) Number
- K993192 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental cement trial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Commercial Distribution
- Not 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
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
Choice 2 Try-In Paste by Bisco Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K993192 also covers:
- Choice 2 Try-In Paste — BISCO INC.
- Choice 2 Try-In Paste — BISCO INC.
- Choice 2 Try-In Paste — BISCO INC.
- Choice 2 Try-In Paste — BISCO INC.
- Choice 2 Try-In Paste — BISCO INC.
- Choice 2 Try-In Paste — BISCO INC.
- Choice 2 Try-In Paste — BISCO INC.
- Choice 2 Try-In Paste — BISCO INC.
- Choice 2 Try-In Paste 4 Syringes Kit — BISCO 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
- Bisco Inc.
Sources (1)
- FDA UDI 14e8ef87-527b-4296-89ed-f166981e465f 38 fields · synced May 31, 2026