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Elcomed 100 Types 9925 (W&H- and Innova-Version) and 9927 (Astra-Version), Elcomed 200 Type 9926 (W&H-Version)

by W & H Dentalwerk

510(k) K972889

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 NumberK972889 Date22 Jan 1998ClearedStatusActive

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  • Withdrawn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
EBW
Device Class
Class I
Regulation
21 CFR Part 872.4200
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent