Cleared Traditional

K053379 - RELI-ON ONE STEP, ORTHODONTIC ADHESIVE

K053379 is an FDA 510(k) clearance for RELI-ON ONE STEP, manufactured by Classone Orthodontics, Inc.. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K053379 · Classone Orthodontics, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
51d
Days
Class 2
Risk

K053379 is an FDA 510(k) clearance for the RELI-ON ONE STEP, ORTHODONTIC ADHESIVE. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Classone Orthodontics, Inc. (Lubbock, US). The FDA issued a Cleared decision on January 25, 2006 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3750 - 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 Classone Orthodontics, Inc. devices

FDA 510(k) Submission Details - K053379

510(k) Number K053379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2005
Decision Date January 25, 2006
Days to Decision 51 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
76d faster than avg
Panel avg: 127d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYH Device Classification - Class 2, Special Controls

Product Code DYH Adhesive, Bracket And Tooth Conditioner, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3750
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 - DYH Adhesive, Bracket And Tooth Conditioner, Resin

All 135
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K053379.
GC MODELS OPA-100 AND JC-50
K073588 · GC America, Inc. · Feb 2008
THERMA-CURE
K071590 · Reliance Orthodontic Products, Inc. · Jul 2007
GRENGLOO
K061481 · Ormco Corp. · Jul 2006
LC BRACKET ADHESIVE SYSTEM
K050750 · Dentsply Intl. · Apr 2005
D3 CHROMA
K042422 · Sybron Dental Specialties, Inc. · Nov 2004
IDEAL 1 ORTHODONTIC BAND CEMENT
K040375 · Dentsply Intl. · Apr 2004