Cleared Traditional

K880393 - TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVE

K880393 is the FDA 510(k) clearance for TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVE by Unitek Corp.. It is a Class 2 Dental device (product code DYH) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K880393 · Unitek Corp. · Dental device
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Mar 1988
Decision
62d
Days
Class 2
Risk

K880393 is an FDA 510(k) clearance for the TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVE. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Unitek Corp. (Monrovia, US). The FDA issued a Cleared decision on March 31, 1988 after a review of 62 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 Unitek Corp. devices

Submission Details

510(k) Number K880393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1988
Decision Date March 31, 1988
Days to Decision 62 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 127d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 121
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K880393.
RELIANCE METAL PRIMER
K880766 · Reliance Orthodontic Products, Inc. · Apr 1988
PORCELAIN PRIMER
K880790 · Reliance Orthodontic Products, Inc. · Apr 1988
PLASTIC PRIMER
K880792 · Reliance Orthodontic Products, Inc. · Apr 1988
PHASE II
K875142 · Reliance Orthodontic Products, Inc. · Feb 1988
EXCEL REGULAR SET
K875141 · Reliance Orthodontic Products, Inc. · Feb 1988
RELY-A-BOND(NO MIX ORTHODONTIC ADHESIVE)
K875143 · Reliance Orthodontic Products, Inc. · Feb 1988