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N1 TiUltra TCC Implant System

by Nobel Biocare Services AG

510(k) K211109

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 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 NumberK211109 Date21 Dec 2021ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-1101-2025 FDA Class II initiated 10 Jan 2025

    Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.

    • Ongoing Z-1565-2022 FDA Class II initiated 25 Jul 2022

    Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.

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  • Withdrawn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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