Retrax Solution 40 mL

FDA UDI

Class U (US FDA UDI)

by Pascal Company, Inc.

Identity

Trade Name: Retrax Solution 40 mL FDA UDI
Generic Name: Gingival retraction solution FDA UDI
Device Name: Flavored Hemostatic retraction solution for topical dental application with 25% aluminum sulfate, 40 mL FDA UDI
Model / Reference: 15610 FDA UDI
Description: Flavored Hemostatic retraction solution for topical dental application with 25% aluminum sulfate, 40 mL FDA UDI

Identifiers

Catalog Number: 15610 FDA UDI
Primary DI / UDI-DI: 00310866000824 FDA UDI
FDA Product Code: MVL FDA UDI
GMDN Term: Gingival retraction solution FDA UDI

Classification

Device Class: U 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Gingival retraction solution

Retrax Solution 40 mL by Pascal Company, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Gingival retraction solution.

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Hemoban® Gel 25% Aluminum Chloride Hemostatic Solution — Dentsply International · U
Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY · Class II
HSEU — HENRY SCHEIN, INC. · U
ViscoStat Clear — ULTRADENT PRODUCTS, INC. · U
FASTRACT — BENCO DENTAL SUPPLY CO. · U

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 U	Pending data

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Manufacturer

Manufacturer: Pascal Company, Inc.

Sources (1)

FDA UDI fd517246-a38d-4e8b-b5ee-2b88e3a34fb4 36 fields · synced May 30, 2026