Skip to content

Ketac-Molar Quick

by Espe Dental AG 510(k)

Active United States

510(k) K994251

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK994251 Date3 Jan 2000ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
EBF
Device Class
Class II
Regulation
21 CFR Part 872.3690
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Other devices from Espe Dental AG

  • Hytac

    Class II

  • Impregum Penta M Monosoft

    Class II

  • Pentamix 2

    Class I

  • Vitron M

    Class II

  • Vestogum

    Class II

  • Ketac Cem U

    Class II

See all devices from Espe Dental AG →