Cleared Traditional

K073697 - TRANSBOND SUPREME ADHESIVE

K073697 is an FDA 510(k) clearance for TRANSBOND SUPREME ADHESIVE, 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 46-day FDA review.

K073697 · 3M Unitek · Dental device
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Feb 2008
Decision
46d
Days
Class 2
Risk

K073697 is an FDA 510(k) clearance for the TRANSBOND SUPREME 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 February 15, 2008 after a review of 46 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.

FDA 510(k) Submission Details - K073697

510(k) Number K073697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2007
Decision Date February 15, 2008
Days to Decision 46 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 128d · This submission: 46d
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 175
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K073697.
GC OPB-100
K080724 · GC America, Inc. · Jun 2008
PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION
K081291 · Dentsply Interntional · May 2008
GC MODELS OPA-100 AND JC-50
K073588 · GC America, Inc. · Feb 2008
TENDER ORTHO BOND-ENA BOND-ENA ETCH
K072978 · Micerium S.P.A. · Jan 2008
RM BOND, MODEL J032
K072830 · Pentron Clinical Technologies · Dec 2007
THERMA-CURE
K071590 · Reliance Orthodontic Products, Inc. · Jul 2007
K073697 · TRANSBOND SUPREME ADHESIVE
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