Nupro®

FDA UDI

Class II (US FDA UDI)

by Dentsply Professional

Identity

Trade Name: NUPRO® FDA UDI
Generic Name: Dental cavity varnish FDA UDI
Device Name: NUPRO® 5% Sodium Fluoride White Varnish, Patient Dose Kit - BubbleGum. Contents: Integrated Brush, 50 Patient Doses of 0.4g FDA UDI
Model / Reference: 130312 FDA UDI
Description: NUPRO® 5% Sodium Fluoride White Varnish, Patient Dose Kit - BubbleGum. Contents: Integrated Brush, 50 Patient Doses of 0.4g FDA UDI

Identifiers

Primary DI / UDI-DI: D0031303121 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

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
SciPharm Copal Cavity Varnish — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
SciPharm Fluoroseal Cavity Liner — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
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 cf53d517-ca6e-47b2-834a-347d6485504c 36 fields · synced May 29, 2026