Identity
- Trade Name
- NUPRO® FDA UDI
- Generic Name
- Dental cavity varnish FDA UDI
- Device Name
- NUPRO® 5% Sodium Fluoride White Varnish, Patient Dose Kit - Mint. Contents: Integrated Brush, 500 Patient Doses of 0.4g. FDA UDI
- Model / Reference
- 130324 FDA UDI
- Description
- NUPRO® 5% Sodium Fluoride White Varnish, Patient Dose Kit - Mint. Contents: Integrated Brush, 500 Patient Doses of 0.4g. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D0031303241 FDA UDI
- FDA Product Code
- LBH FDA UDI
- GMDN Term
- Dental cavity varnish 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 0.4 Gram FDA UDI
Category: Dental cavity varnish
Nupro® by Dentsply Professional — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental cavity varnish.
- Fluorodose — CENTRIX, INC. · Class II
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- Hydroxyline — Taub Products · Class II
- 3M™ — 3M COMPANY · Class II
- Durashield® CV — Sultan Healthcare Inc · Class II
- Vanish™ Varnish — 3M COMPANY · Class II
- Fluorodose — CENTRIX, 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
- Dentsply Professional
Sources (1)
- FDA UDI fb007c4f-1712-4e78-920c-e8cff90a9f6a 36 fields · synced May 30, 2026