Skip to content

MI Varnish

by Gc America Inc.

510(k) K102808

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK102808 Date22 Dec 2010ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LBH
FDA applicant
GC America, Inc.
Device class
Class II
Regulation
21 CFR Part 872.3260
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

MI Varnish is a dental cavity varnish designed to remineralize enamel and protect teeth from acid attacks. It contains fluoride, calcium, and phosphate, with a proprietary formulation of casein phosphopeptides and amorphous calcium phosphate (CPP-ACP) to enhance enamel acid resistance and prolong fluoride release in the oral cavity.

This product is supplied as a single-use dental application and is intended for professional use in clinical settings. It is not sterile but is packaged to maintain sterility until first use. MI Varnish is classified as a Class II device under FDA regulations (21 CFR 872.3260) and holds a 510(k) clearance for dental use. The product is distributed in a ready-to-use format and requires no additional preparation beyond application to the tooth surface.

Other devices from Gc America Inc.

See all devices from Gc America Inc. →

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is MI Varnish intended for?

    MI Varnish is a dental cavity varnish designed to remineralize enamel and protect teeth from acid attacks. It contains fluoride, calcium, and phosphate, along with a proprietary formulation of casein phosphopeptides and amorphous calcium phosphate (CPP-ACP) to enhance enamel acid resistance and prolong fluoride release in the oral cavity. It is intended for professional use in clinical settings.

  • How is MI Varnish supplied and prepared for use?

    MI Varnish is supplied as a single-use dental application in a ready-to-use format. It requires no additional preparation beyond application to the tooth surface. The product is packaged to maintain sterility until first use, though it is not sterile itself.

  • Is MI Varnish reusable or single-use?

    MI Varnish is designed for single-use only. It is supplied as a single-use dental application intended for one-time professional use in clinical settings. Reuse is not recommended or supported by the product design or labeling.

  • What regulatory pathway was used for MI Varnish?

    MI Varnish received FDA 510(k) clearance under the traditional pathway, with decision code SESE and K-number K102808. It was found substantially equivalent to a predicate device and is classified as a Class II device under 21 CFR 872.3260 for dental use.

  • What storage conditions are recommended for MI Varnish?

    While specific storage conditions are not explicitly stated in the provided data, MI Varnish is packaged to maintain sterility until first use, implying it should be stored in a clean, dry environment at room temperature, protected from direct sunlight and contamination, as is typical for single-use dental products. Always follow the manufacturer’s labeling for storage instructions.