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FLEXIROOT

by Facial Alveodental Implant Rehabilitation, Inc.

510(k) K852305

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 NumberK852305 Date16 Oct 1985ClearedStatusActive

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  • Withdrawn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, 22 Sep 2026

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

FLEXIROOT is a dental device intended for implantation as artificial teeth. It is a substantially equivalent device cleared through the traditional 510(k) pathway.

The device is manufactured by Facial Alveodental Implant Rehabilitation, Inc. and received FDA 510(k) clearance under K852305 with product code DZE. It is supplied as a finished device for dental implantation use.

Questions

AI-generated answers, 22 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 is the FLEXIROOT device used for?

    FLEXIROOT is intended for implantation as an artificial tooth in dental procedures, serving as a substitute for natural teeth to restore function and aesthetics in patients requiring tooth replacement.

  • How is the FLEXIROOT device supplied and is it sterile?

    FLEXIROOT is supplied as a finished device ready for dental implantation use; however, the provided data does not specify sterility status, so users should consult labeling or manufacturer instructions for sterilization and handling requirements prior to use.

  • What regulatory pathway was used for FLEXIROOT clearance?

    FLEXIROOT received clearance through the traditional FDA 510(k) pathway under submission number K852305, demonstrating substantial equivalence to a legally marketed predicate device.