Cleared Traditional

K913854 - ORTHO LIGHT CURE

K913854 is an FDA 510(k) clearance for ORTHO LIGHT CURE, manufactured by Ortho Source. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K913854 · Ortho Source · Dental device
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Jan 1992
Decision
140d
Days
Class 2
Risk

K913854 is an FDA 510(k) clearance for the ORTHO LIGHT CURE. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Ortho Source (North Hollywood, US). The FDA issued a Cleared decision on January 14, 1992 after a review of 140 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 Ortho Source devices

FDA 510(k) Submission Details - K913854

510(k) Number K913854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1991
Decision Date January 14, 1992
Days to Decision 140 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 127d · This submission: 140d
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 151
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K913854.
ORTHODONTIC BRACKET ADHESIVE RESIN MATERIAL
K914317 · Confi-Dental Products Co. · Mar 1992
PORCELAIN PRIMER
K920534 · Confi-Dental Products Co. · Mar 1992
SEQUENCE LIGHT CURE ADHESIVE
K914727 · Ormco Corp. · Jan 1992
PULPDENT ORTHODONTIC BRACKET ADHESIVE
K911286 · Pulpdent Corp. · Jul 1991
ADHESIVE PRECOATED BRACKETS
K911271 · Unitek Corp. · May 1991
PHASE II ORTHODONTIC ADHESIVE
K895523 · Reliance Orthodontic Products, Inc. · Dec 1989