Cleared Traditional

K955503 - ADJUSTABLE PM POSITIONER

K955503 is an FDA 510(k) clearance for ADJUSTABLE PM POSITIONER, manufactured by Jonathan A. Parker, D.D.S.. The device is a Class 2 Dental device with product code LQZ cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K955503 · Jonathan A. Parker, D.D.S. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
69d
Days
Class 2
Risk

K955503 is an FDA 510(k) clearance for the ADJUSTABLE PM POSITIONER. Classified as Device, Jaw Repositioning (product code LQZ), Class II - Special Controls.

Submitted by Jonathan A. Parker, D.D.S. (Washington, US). The FDA issued a Cleared decision on February 8, 1996 after a review of 69 days - a notably fast clearance 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: 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 Jonathan A. Parker, D.D.S. devices

FDA 510(k) Submission Details - K955503

510(k) Number K955503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1995
Decision Date February 08, 1996
Days to Decision 69 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 127d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LQZ Device Classification - Class 2, Special Controls

Product Code LQZ Device, Jaw Repositioning
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.