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Crosstex International

FDA UDI

Class II (US FDA UDI)

by Crosstex International, Inc.

Identity

Trade Name
Crosstex International FDA UDI
Generic Name
Dentifrice FDA UDI
Device Name
ProGuard 5% Sodium Flouride Varnish, Melon FDA UDI
Model / Reference
UFVPML FDA UDI
Description
ProGuard 5% Sodium Flouride Varnish, Melon FDA UDI

Identifiers

Catalog Number
UFVPML FDA UDI
Primary DI / UDI-DI
10732224000319 FDA UDI
510(k) Number
K080814 FDA UDI
FDA Product Code
LBH FDA UDI
GMDN Term
Dentifrice FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3260 FDA UDI
Commercial Distribution
Not 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

No

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

No

FDA UDI

Crosstex International by Crosstex International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K080814 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Crosstex International, Inc.

Sources (1)

  • FDA UDI 9501c8f7-55e4-4bb9-84cf-bb13a6a49ff4 38 fields · synced Jun 8, 2026