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Straumann Bone Level Tapered Implant

by Straumann USA, LLC

510(k) K140878

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK140878 Date20 Aug 2014ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-2935-2026 FDA Class II initiated 16 Jul 2026

    Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest.

    • Terminated Z-0117-2015 FDA Class II initiated 19 Sep 2014

    Assembled with Narrow Connect (NC) transfer piece instead of 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  • Withdrawn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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