Fluorilaq Squeeze Varnish Bubblegum

FDA UDI

Class II (US FDA UDI)

by Pascal Company, Inc.

Identity

Trade Name: Fluorilaq Squeeze Varnish Bubblegum FDA UDI
Generic Name: Dental cavity varnish FDA UDI
Device Name: Fluorilaq Squeeze Bubblegum with 5% Sodium Fluoride Varnish, 9.5 mL squeezable bottlev FDA UDI
Model / Reference: 10420 FDA UDI
Description: Fluorilaq Squeeze Bubblegum with 5% Sodium Fluoride Varnish, 9.5 mL squeezable bottlev FDA UDI

Identifiers

Catalog Number: 10420 FDA UDI
Primary DI / UDI-DI: 00310866001562 FDA UDI
510(k) Number: K030488 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

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

FDA UDI

Category: Dental cavity varnish

Fluorilaq Squeeze Varnish Bubblegum by Pascal Company, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Dental cavity varnish.

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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

K030488 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: Pascal Company, Inc.

Sources (1)

FDA UDI 2b1ca0e2-d65a-44d3-8ac6-d6c7d6d643c8 37 fields · synced Jun 6, 2026