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Vertex Sealand L/C Orthodontic Sealant

by Apex Dental Materials, Inc.

510(k) K010547

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 NumberK010547 Date16 Aug 2001ClearedStatusActive

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  • Withdrawn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
KLE
Device Class
Class II
Regulation
21 CFR Part 872.3200
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

The Vertex Sealand L/C Orthodontic Sealant is a resin tooth bonding agent. It is intended to be applied to the interior of a prepared tooth cavity to improve the retention of dental restorations such as fillings.

This device is regulated under 21 CFR 872.3200 and has received FDA 510(k) clearance under K010547. It is manufactured by Apex Dental Materials, Inc. and is categorized under the dental medical specialty.

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