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Mis Crest Widener

by Mis - Implant Technologies, Ltd.

510(k) K080458

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK080458 Date17 Dec 2008ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
MQN
FDA applicant
Mis - Implant Technologies , Ltd.
Device class
Class II
Regulation
21 CFR Part 872.4760
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.

The Mis Crest Widener is an external mandibular fixator and distractor designed as a mechanical distraction osteogenesis device. It is used to widen narrow alveolar ridges that have sufficient height to prepare the ridge for dental implantation, allowing for the correct lateral positioning of the implant while avoiding bone augmentation.

The device consists of four arms, guiding pins, and an activating screw, and is manufactured from medical grade 5 Titanium alloy. It is identified by model number MK-CW28 and has received FDA 510(k) clearance.

Other devices from MIS Implants Technologies Ltd.

See all devices from MIS Implants Technologies Ltd. →

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 primary clinical purpose of the Mis Crest Widener?

    This device is a mechanical distraction osteogenesis tool used to widen narrow alveolar ridges that possess sufficient height. By widening the ridge, it prepares the site for dental implantation, allowing for correct lateral positioning of the implant while avoiding the need for bone augmentation.

  • What materials are used to manufacture the Mis Crest Widener?

    The device is constructed from medical grade 5 Titanium alloy. This material is selected for its biocompatibility and mechanical properties, which are necessary for its function as an external mandibular fixator and distractor.

  • What components make up the MK-CW28 model?

    The Mis Crest Widener model MK-CW28 consists of four arms, guiding pins, and an activating screw. These components work together to facilitate the mechanical distraction process required for ridge widening.

  • Has this device received regulatory clearance?

    Yes, the Mis Crest Widener has received FDA 510(k) clearance under the k-number K080458. It is classified as an external mandibular fixator and distractor under the dental medical specialty.