Cleared Traditional

MIS CREST WIDENER (K080458) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K080458 · Mis - Implant Technologies , Ltd. · Dental device
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Dec 2008
Decision
301d
Days
Class 2
Risk

K080458 is an FDA 510(k) clearance for the MIS CREST WIDENER. Classified as External Mandibular Fixator And/or Distractor (product code MQN), Class II - Special Controls.

Submitted by Mis - Implant Technologies , Ltd. (Shlomi, IL). The FDA issued a Cleared decision on December 17, 2008 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Mis - Implant Technologies , Ltd. devices

Submission Details

510(k) Number K080458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2008
Decision Date December 17, 2008
Days to Decision 301 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
174d slower than avg
Panel avg: 127d · This submission: 301d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQN External Mandibular Fixator And/or Distractor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - MQN External Mandibular Fixator And/or Distractor

All 59
Devices cleared under the same product code (MQN) and FDA review panel - the closest regulatory comparables to K080458.
KLS Martin IPS Distraction
K220050 · KLS-Martin L.P. · Aug 2022
DePuy Synthes Maxillofacial Portfolio - MR Conditional
K183113 · Synthes USA Products, LLC · Mar 2019
Stryker Pediatric Mandibular Distractor 2
K181504 · Stryker · Sep 2018
SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM
K080153 · Synthes (Usa) · May 2008
SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT
K062299 · Synthes (Usa) · Aug 2006
SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM
K060138 · Synthes (Usa) · Jun 2006