Skip to content

Protemp H

by Espe Dental AG

510(k) K002364

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 · Special NumberK002364 Date10 Aug 2000ClearedStatusActive

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  • Withdrawn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
EBG
Device Class
Class II
Regulation
21 CFR Part 872.3770
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 →