Identity
- Trade Name
- NovaBright FDA UDI
- Generic Name
- Fluoride gel FDA UDI
- Device Name
- 0.4mL 5% Sodium Fluoride Varnish (Bubblegum) - 1 Unit FDA UDI
- Model / Reference
- 14202-001 FDA UDI
- Description
- 0.4mL 5% Sodium Fluoride Varnish (Bubblegum) - 1 Unit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816537020943 FDA UDI
- FDA Product Code
- LBH FDA UDI
- GMDN Term
- Fluoride gel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3260 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: Fluoride gel
NovaBright by Nanova Biomaterials Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fluoride gel.
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- NovaBright — NANOVA BIOMATERIALS INC · Class II
- NovaBright — NANOVA BIOMATERIALS INC · Class II
- NovaBright — NANOVA BIOMATERIALS INC · Class II
- NovaBright — NANOVA BIOMATERIALS INC · Class II
- NovaBright — NANOVA BIOMATERIALS INC · Class II
- NovaBright — NANOVA BIOMATERIALS 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 |
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Manufacturer
- Manufacturer
- Nanova Biomaterials Inc
Sources (1)
- FDA UDI 3b24908e-f187-4092-88a7-f24428d2ac8b 34 fields · synced May 30, 2026