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Restore Self Tapping Dental Implant System

by Lifecore Biomedical, Inc.

510(k) K954512

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 NumberK954512 Date23 Feb 1996ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Restore Self-Tapping Dental Implant System is a dental implant designed for osseointegration in the jawbone. It features a self-tapping mechanism to facilitate precise placement without additional drilling, aiding in the restoration of single-tooth or multi-tooth dental defects.

This system is intended for use in clinical dental settings and is supplied sterile for single-use. It is classified under product code DZE and has received FDA 510(k) clearance (K954512) as substantially equivalent to a predicate device. No additional regulatory markings or MRI safety classifications are specified.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of dental defects is the Restore Self-Tapping Dental Implant System intended to address in clinical practice?

    The Restore Self-Tapping Dental Implant System is designed specifically for restoring single-tooth or multi-tooth dental defects by facilitating osseointegration in the jawbone. Its self-tapping mechanism simplifies precise placement, making it suitable for replacing missing teeth in clinical dental settings.

  • Is the Restore Self-Tapping Dental Implant System reusable or intended for single-use, and how is it supplied?

    The Restore Self-Tapping Dental Implant System is supplied sterile and intended for single-use only. This ensures patient safety and maintains sterility during dental procedures, as it is not designed for reuse.

  • What regulatory pathway was followed for FDA clearance of this dental implant system?

    The Restore Self-Tapping Dental Implant System received FDA 510(k) clearance (K954512) under the Traditional Review pathway, with a decision classification of *Substantially Equivalent* to a predicate device. It was reviewed by the Dental (DE) Advisory Committee and falls under product code DZE.

  • Does the system require additional drilling before placement, and how does the self-tapping feature work?

    No, the Restore Self-Tapping Dental Implant System is engineered with a self-tapping mechanism, eliminating the need for extra drilling. This feature allows for precise, direct insertion into the jawbone, streamlining the implant procedure while maintaining stability for osseointegration.