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Espe Ketac-Bond

by Espe GmbH (Us) 510(k)

Active United States

510(k) K844845

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK844845 Date19 Aug 1985ClearedStatusActive

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  • Withdrawn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
EBD
Device Class
Class II
Regulation
21 CFR Part 872.3310
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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