Sparkle V Sodium Fluoride Varnish, Melon

FDA UDI

Class II (US FDA UDI)

by Crosstex International, Inc.

Identity

Trade Name: Sparkle V Sodium Fluoride Varnish, Melon FDA UDI
Generic Name: Dental cavity varnish FDA UDI
Device Name: Sodium Fluoride Varnish, Melon FDA UDI
Model / Reference: UFVML FDA UDI
Description: Sodium Fluoride Varnish, Melon FDA UDI

Identifiers

Primary DI / UDI-DI: 10732224005574 FDA UDI
510(k) Number: K040098 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

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

FDA UDI

Category: Dental cavity varnish

Sparkle V Sodium Fluoride Varnish, Melon by Crosstex International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental cavity varnish.

NUPRO® — Dentsply Professional · Class II
Fluorodose — CENTRIX, INC. · Class II
NUPRO® — Dentsply Professional · Class II
NUPRO® — Dentsply Professional · 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
NUPRO® — Dentsply Professional · Class II

Cleared under the same submission

K040098 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: Crosstex International, Inc.

Sources (1)

FDA UDI c3fbabd6-9274-447c-bd8f-3044d82f73ae 35 fields · synced Jun 8, 2026