Cleared Traditional

NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR (K952847) - FDA 510(k) Clearance

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

K952847 · Ace Surgical Supply Co., Inc. · Dental device
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Feb 1996
Decision
230d
Days
Class 2
Risk

K952847 is an FDA 510(k) clearance for the NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR. Classified as External Mandibular Fixator And/or Distractor (product code MQN), Class II - Special Controls.

Submitted by Ace Surgical Supply Co., Inc. (Brockton, US). The FDA issued a Cleared decision on February 6, 1996 after a review of 230 days - an extended review cycle.

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. Standard predicate reliance. 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 Ace Surgical Supply Co., Inc. devices

Submission Details

510(k) Number K952847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1995
Decision Date February 06, 1996
Days to Decision 230 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 127d · This submission: 230d
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 K952847.
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