Cleared Traditional

K080445 - LION SE ONE STEP ORTHODONTIC ADHESIVE

K080445 is an FDA 510(k) clearance for LION SE ONE STEP ORTHODONTIC ADHESIVE, 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 148-day FDA review.

K080445 · Classone Orthodontics, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
148d
Days
Class 2
Risk

K080445 is an FDA 510(k) clearance for the LION SE 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 July 16, 2008 after a review of 148 days - within the typical 510(k) review window.

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: 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.

View all Classone Orthodontics, Inc. devices

FDA 510(k) Submission Details - K080445

510(k) Number K080445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2008
Decision Date July 16, 2008
Days to Decision 148 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
21d slower than avg
Panel avg: 127d · This submission: 148d
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 K080445.
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FLOWTAIN & FLOWTAIN LV
K083051 · Reliance Orthodontic Products, Inc. · Feb 2009
GC OPB-100
K080724 · GC America, Inc. · Jun 2008
GC MODELS OPA-100 AND JC-50
K073588 · GC America, Inc. · Feb 2008
THERMA-CURE
K071590 · Reliance Orthodontic Products, Inc. · Jul 2007