Cleared Traditional

K984117 - INNOVA TELESCOPIC DISTRACTOR

K984117 is an FDA 510(k) clearance for INNOVA TELESCOPIC DISTRACTOR, manufactured by Innova Corp.. The device is a Class 2 Dental device with product code MQN cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K984117 · Innova Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
85d
Days
Class 2
Risk

K984117 is an FDA 510(k) clearance for the INNOVA TELESCOPIC DISTRACTOR. Classified as External Mandibular Fixator And/or Distractor (product code MQN), Class II - Special Controls.

Submitted by Innova Corp. (Washington, US). The FDA issued a Cleared decision on February 10, 1999 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Innova Corp. devices

FDA 510(k) Submission Details - K984117

510(k) Number K984117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1998
Decision Date February 10, 1999
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 127d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQN Device Classification - Class 2, Special Controls

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 48
Devices cleared under the same product code (MQN) and FDA review panel - the closest regulatory comparables to K984117.
LORENZ EXTERNAL MANDIBULAR DISTRACTOR
K992873 · Walter Lorenz Surgical, Inc. · Sep 1999
K-L-W INTRAORAL DISTRACTOR
K991875 · KLS-Martin L.P. · Aug 1999
OSTEOMED INTRAORAL DISTRACTION SYSTEM
K990944 · Osteomed Corp. · Jun 1999
KLS MARTIN INTRAORAL ZURICH RAMUS DISTRACTOR
K983809 · KLS-Martin L.P. · Jan 1999
KLS INTRAORAL VERTICAL DISTRACTOR
K983515 · KLS-Martin L.P. · Nov 1998
LORENZ INTRAORAL LINEAR MANDIBULAR DISTRACTION SYSTEM
K982906 · Walter Lorenz Surgical, Inc. · Nov 1998