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3m™

FDA UDI

Class II (US FDA UDI)

by 3m Company

Identity

Trade Name
3M™ FDA UDI
Generic Name
Dental cavity varnish FDA UDI
Device Name
3M™ Fast Release Varnish 5% Sodium Fluoride, 12158M, Mint Flavor, 200 0.4 mL Unit Dose FDA UDI
Model / Reference
12158M FDA UDI
Description
3M™ Fast Release Varnish 5% Sodium Fluoride, 12158M, Mint Flavor, 200 0.4 mL Unit Dose FDA UDI

Identifiers

Catalog Number
12158M FDA UDI
Primary DI / UDI-DI
10605861078525 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental cavity varnish

3m™ by 3m Company — 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
3m Company

Sources (1)

  • FDA UDI 354cb956-89f6-450d-bc9b-59790dfd8d53 35 fields · synced May 30, 2026