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Endosseous Dental Implant System

by Southern Implants, Inc. 4 variants

510(k) K071161

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK071161 Date16 Nov 2007ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0718-2018 FDA Class II initiated 16 Jun 2017

    An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label.

    • Terminated Z-1265-2015 FDA Class II initiated 23 Jan 2015

    Z-MAX Implant, 9mm diameter, 7mm length labeled package, catalog number Z-MAX9-7, contained a MAX-TL Implant, 9mm diameter, 7mm length. And vice versa.

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  • Withdrawn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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