Skip to content

Restore Hex Cylinder Endosseous System

by Lifecore Biomedical, Inc.

510(k) K931468

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 NumberK931468 Date12 Jul 1994ClearedStatusActive

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  • Withdrawn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, 6 Oct 2026

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

This device is a dental endosseous implant system designed for use in the jawbone to support prosthetic teeth. It consists of a hexagonal cylinder component intended for osseointegration in dental applications.

It is supplied as a reusable or single-use device (specifics not stated in data) and is indicated for dental use. The device received FDA 510(k) clearance K931468 on July 12, 1994, and is classified as a Class 2 device with product code DZE. No information on sterility, MRI safety, sizes, or storage is provided in the data.

Other devices from Lifecore Biomedical, Inc.

See all devices from Lifecore Biomedical, Inc. →

Questions

AI-generated answers, 6 Oct 2026

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

  • What is the RESTORE HEX CYLINDER ENDOSSEOUS SYSTEM used for?

    This device is a dental endosseous implant system designed for use in the jawbone to support prosthetic teeth, consisting of a hexagonal cylinder component intended for osseointegration in dental applications, as stated in the device description.

  • How is the RESTORE HEX CYLINDER ENDOSSEOUS SYSTEM supplied and is it reusable or single-use?

    The device is supplied as either reusable or single-use, though the data does not specify which applications or components correspond to each use type, so users must consult current labeling or manufacturer instructions for specific reuse guidelines.

  • What regulatory clearance does the RESTORE HEX CYLINDER ENDOSSEOUS SYSTEM have and when was it granted?

    The device received FDA 510(k) clearance under number K931468 on July 12, 1994, and is classified as a Class 2 medical device with product code DZE, based on a traditional submission process.