Cleared Traditional

K012673 - PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM

K012673 is an FDA 510(k) clearance for PRIME-DENT ONE-STEP ORTHODONTIC ADHESIV..., manufactured by Prime Dental Manufacturing, Inc.. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K012673 · Prime Dental Manufacturing, Inc. · Dental device
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Oct 2001
Decision
71d
Days
Class 2
Risk

K012673 is an FDA 510(k) clearance for the PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Prime Dental Manufacturing, Inc. (Chicago, US). The FDA issued a Cleared decision on October 24, 2001 after a review of 71 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 Prime Dental Manufacturing, Inc. devices

FDA 510(k) Submission Details - K012673

510(k) Number K012673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2001
Decision Date October 24, 2001
Days to Decision 71 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
56d faster than avg
Panel avg: 127d · This submission: 71d
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
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K012673.
PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT
K014138 · Pulpdent Corp. · Mar 2002
PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM
K020115 · Pulpdent Corp. · Feb 2002
PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE
K014059 · Pulpdent Corp. · Feb 2002
FIRST SPEP
K012032 · Bisco, Inc. · Sep 2001
IMPROVED ENLIGHT LV
K001881 · Sybron Dental Specialties, Inc. · Aug 2000
LIGHT-CURED ORTHODONTIC BAND CEMENT
K001446 · Scientific Pharmaceuticals, Inc. · Jul 2000