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Sealant, New Filled

by L.D. Caulk Co. 510(k)

Active United States

510(k) K760405

Overview

The Sealant, New Filled is a dental device used for pit and fissure sealing. It is a Class II medical device manufactured by L.D. Caulk Co. and is designed to prevent dental caries by sealing pits and fissures on the chewing surfaces of teeth.

This device is supplied as a single-use product and is regulated under FDA 510(k) clearance with the product code EBC. It was cleared on August 23, 1976, and is intended for dental applications. The device is not specified as MRI safe and no information regarding sterility or storage conditions is provided in the data.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK760405 Date23 Aug 1976ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
EBC
Device Class
Class II
Regulation
21 CFR Part 872.3765
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Sealant New Filled used for?

    The Sealant New Filled is a dental device designed to prevent dental caries by sealing pits and fissures on the chewing surfaces of teeth. It is a Class II medical device manufactured by L.D. Caulk Co.

  • Is the Sealant New Filled a single-use product?

    Yes, the Sealant New Filled is supplied as a single-use product. It is not intended for reuse and should be discarded after a single application.

  • What is the regulatory status of the Sealant New Filled?

    The Sealant New Filled is regulated under FDA 510(k) clearance with the product code EBC. It was cleared on August 23, 1976, and is intended for dental applications.

  • Is the Sealant New Filled MRI safe?

    The device data does not specify whether the Sealant New Filled is MRI safe. Clinicians should consult the manufacturer's instructions for use or contact L.D. Caulk Co. for specific information regarding MRI compatibility.