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Embrace Varnish - 5% Sodium Fluoride With Cxp™

FDA UDI

Class II (US FDA UDI)

by Pulpdent Corporation

Identity

Trade Name
EMBRACE VARNISH - 5% SODIUM FLUORIDE WITH CXP™ FDA UDI
Generic Name
Dental cavity varnish FDA UDI
Device Name
50 x 0.4 mL Embrace Varnish unit dose with applicator brush FDA UDI
Model / Reference
FV50 FDA UDI
Description
50 x 0.4 mL Embrace Varnish unit dose with applicator brush FDA UDI

Identifiers

Primary DI / UDI-DI
D701FV502 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Dimensions & Sizes

Size
Total Volume — 0.4 Milliliter FDA UDI

Category: Dental cavity varnish

Embrace Varnish - 5% Sodium Fluoride With Cxp™ by Pulpdent Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental cavity varnish.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pulpdent Corporation

Sources (1)

  • FDA UDI f4bbfae9-8a4f-45c9-b3fb-fb0d731d115a 34 fields · synced Jun 9, 2026