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Bl, 04.1 Mm Rc, Slactive 8mm, Tizr and 10mm, 12, 14mm

by Straumann USA

510(k) K121131

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK121131 Date6 Jun 2012ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0174-2015 FDA Class II initiated 24 Sep 2014

    Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)

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  • Withdrawn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
DZE
Device Class
Class II
Regulation
21 CFR Part 872.3640
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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