Cleared Traditional

K091533 - SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200

K091533 is an FDA 510(k) clearance for SLICKS SECTIONAL MATRIX AND MATRIX BANDS, manufactured by Garrison Dental Solutions. The device is a Class 1 Dental device with product code JEP cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K091533 · Garrison Dental Solutions · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
83d
Days
Class 1
Risk

K091533 is an FDA 510(k) clearance for the SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, .... Classified as Retainer, Matrix (product code JEP), Class I - General Controls.

Submitted by Garrison Dental Solutions (Shelton, US). The FDA issued a Cleared decision on August 17, 2009 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 Garrison Dental Solutions devices

FDA 510(k) Submission Details - K091533

510(k) Number K091533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2009
Decision Date August 17, 2009
Days to Decision 83 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
44d faster than avg
Panel avg: 127d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

JEP Device Classification - Class 1, General Controls

Product Code JEP Retainer, Matrix
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.