Safco Fluoride Varnish

FDA UDI

Class II (US FDA UDI)

by Safco Dental Supply

Identity

Trade Name: Safco Fluoride Varnish FDA UDI
Generic Name: Dental coating, tooth-desensitizing FDA UDI
Device Name: Safco 5% fluoride varnish mint FDA UDI
Model / Reference: 102-8523 FDA UDI
Description: Safco 5% fluoride varnish mint FDA UDI

Identifiers

Catalog Number: 102-8523 FDA UDI
Primary DI / UDI-DI: D723102852334 FDA UDI
FDA Product Code: LBH FDA UDI
GMDN Term: Dental coating, tooth-desensitizing 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

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

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental coating, tooth-desensitizing

Safco Fluoride Varnish is a popular, over-the-counter (OTC) dental coating designed to treat dental hypersensitivity caused by physical, chemical, and physiological agents. The varnish contains 5% fluoride, making it an effective solution for individuals with sensitive teeth. Safco Fluoride Varnish is available in various sizes and is suitable for use in the home or healthcare facility.

Similar devices

Also classified as Dental coating, tooth-desensitizing.

Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class II
VELLA 5% Sodium Fluoride Varnish Case of 12 Boxes 35 Caramel — Preventech · Class II
Varnish, Bulk, Oral-B, Bubblegum 1800 — YOUNG DENTAL MANUFACTURING I, LLC · Class II
VOCO Profluorid Varnish — VOCO GmbH · Class II
NovaBright — NANOVA BIOMATERIALS INC · Class II
IRIS — BENCO DENTAL SUPPLY CO. · Class II
Pulp Canal Sealer — KERR ITALIA SRL · Class IIa
MICROPRIME — DANVILLE MATERIALS, LLC · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Safco Dental Supply

Sources (1)

FDA UDI a32aa536-c882-44ff-aad7-fabdb2bc5ddd 35 fields · synced Jul 3, 2026