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PerioType Rapid

by Clinical House Europe GmbH

510(k) K143758

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 NumberK143758 Date7 Aug 2015ClearedStatusActive

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  • Withdrawn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, 25 Sep 2026

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

PerioType Rapid is a dental implant designed for periointegration, which is the unirritated embedding of an endosseous tooth implant in the surrounding oral mucosa free of inflammation. It is a bone level implant with an internal connection and custom shape. The device is manufactured by Clinical House Europe GmbH.

PerioType Rapid is supplied as a Class 2 dental device with product code DZE. It received FDA 510(k) clearance through the Traditional pathway on August 7, 2015, with K-number K143758. The device is intended for use in dental applications and is available in various sizes as specified by the manufacturer.

Other devices from Clinical House Europe GmbH

Questions

AI-generated answers, 25 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 PerioType Rapid used for?

    PerioType Rapid is a dental implant designed for periointegration, which is the unirritated embedding of an endosseous tooth implant in the surrounding oral mucosa free of inflammation. It is a bone level implant with an internal connection and custom shape.

  • How is PerioType Rapid supplied?

    PerioType Rapid is supplied as a Class 2 dental device with product code DZE. It is available in various sizes as specified by the manufacturer, Clinical House Europe GmbH.

  • What is the regulatory status of PerioType Rapid?

    PerioType Rapid received FDA 510(k) clearance through the Traditional pathway on August 7, 2015, with K-number K143758. It is intended for use in dental applications.

  • Is PerioType Rapid a single-use device?

    The device data does not specify whether PerioType Rapid is single-use or reusable. For information regarding sterility and reuse, please consult the manufacturer's instructions for use.