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Periotype X-Pert

by Clinical House Europe GmbH

510(k) K123386

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 NumberK123386 Date26 Apr 2013ClearedStatusActive

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  • Withdrawn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, 27 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 Periotype X-Pert is a dental implant, specifically an endosseous root-form implant, as classified under product code DZE. It is a bone level implant with a custom octagon-shaped connection.

It is supplied as a sterile, single-use device intended for dental implantation. The device received FDA 510(k) clearance (K123386) on April 26, 2013, and is classified as a Class II medical device subject to special controls.

Other devices from Clinical House Europe GmbH

Questions

AI-generated answers, 27 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 Periotype X-Pert used for?

    The Periotype X-Pert is an endosseous root-form dental implant designed for dental implantation, specifically intended for bone-level placement in the jaw to support prosthetic teeth.

  • How is the Periotype X-Pert supplied and is it reusable?

    The Periotype X-Pert is supplied as a sterile, single-use device, meaning it is intended for one procedure only and must not be reprocessed or reused to ensure patient safety and maintain sterility.

  • What distinguishes the Periotype X-Pert from other dental implants?

    The Periotype X-Pert features a custom octagon-shaped connection and is classified as a bone level implant, which differentiates its interface and placement depth compared to other implant designs.