Cleared Traditional

K100536 - TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE

K100536 is an FDA 510(k) clearance for TRANSBOND IDB PRE-MIX CHEMICAL CARE ADH..., manufactured by 3M Unitek. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K100536 · 3M Unitek · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
152d
Days
Class 2
Risk

K100536 is an FDA 510(k) clearance for the TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by 3M Unitek (Monrovia, US). The FDA issued a Cleared decision on July 27, 2010 after a review of 152 days - an extended review 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: 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 3M Unitek devices

FDA 510(k) Submission Details - K100536

510(k) Number K100536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2010
Decision Date July 27, 2010
Days to Decision 152 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
25d slower than avg
Panel avg: 127d · This submission: 152d
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 134
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