Cleared Traditional

K133683 - MICR02 OSA DEVICE

K133683 is an FDA 510(k) clearance for MICR02 OSA DEVICE, manufactured by Microdental, Inc.. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K133683 · Microdental, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
234d
Days
Class 2
Risk

K133683 is an FDA 510(k) clearance for the MICR02 OSA DEVICE. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Microdental, Inc. (Dublin, US). The FDA issued a Cleared decision on July 24, 2014 after a review of 234 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5570 - 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.

FDA 510(k) Submission Details - K133683

510(k) Number K133683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2013
Decision Date July 24, 2014
Days to Decision 234 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
106d slower than avg
Panel avg: 128d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRK Device Classification - Class 2, Special Controls

Product Code LRK Device, Anti-snoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5570
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 - LRK Device, Anti-snoring

All 207
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K133683.
NDX DORSAL APPLIANCE
K133390 · Institute For Quality Resource Management · Oct 2014
CRANE ACRYLIC HERBST APPLIANCE
K140429 · Crane Dental Laboratory, Inc. · Sep 2014
ZQUIET-SA
K140777 · Sleeping Well, LLC · Jul 2014
MEDLEY GOLD
K140435 · American Dental Sleep Medicine, Ip, LLC · Jun 2014
SOMNODENT FUSION, CLASSIC
K140278 · Somnomed, Inc. · Jun 2014
SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY
K132506 · Michael D Williams Dds PA · May 2014