Identity
- Trade Name
- FluoroCal FDA UDI
- Generic Name
- Dental coating, tooth-desensitizing, professional FDA UDI
- Device Name
- FluoroCal 50ct Unit Dose Pkg Bubble Gum FDA UDI
- Model / Reference
- B-30502K FDA UDI
- Description
- FluoroCal 50ct Unit Dose Pkg Bubble Gum FDA UDI
Identifiers
- Catalog Number
- B-30502K FDA UDI
- Primary DI / UDI-DI
- 10810111542873 FDA UDI
- 510(k) Number
- K182917 FDA UDI
- FDA Product Code
- LBH FDA UDI
- GMDN Term
- Dental coating, tooth-desensitizing, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3260 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
FluoroCal by Bisco Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K182917 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 |
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Manufacturer
- Manufacturer
- Bisco Inc.
Sources (1)
- FDA UDI 951b14b7-155c-4f92-a828-ca497af3a4ea 38 fields · synced May 30, 2026