Cleared Traditional

K832292 - SOLO-TACH

K832292 is an FDA 510(k) clearance for SOLO-TACH, manufactured by Dentsply Intl.. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K832292 · Dentsply Intl. · Dental device
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Sep 1983
Decision
50d
Days
Class 2
Risk

K832292 is an FDA 510(k) clearance for the SOLO-TACH. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Dentsply Intl. (Mchenry, US). The FDA issued a Cleared decision on September 1, 1983 after a review of 50 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 Dentsply Intl. devices

FDA 510(k) Submission Details - K832292

510(k) Number K832292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1983
Decision Date September 01, 1983
Days to Decision 50 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 127d · This submission: 50d
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 148
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K832292.
CLEANSE N BOND I
K844133 · Lee Pharmaceuticals · Jan 1985
CLEANSE N BOND II
K844134 · Lee Pharmaceuticals · Jan 1985
BOSWORTH SUPER BOND DENTAL ADHESIVE
K842448 · Harry J. Bosworth Co. · Sep 1984
NO-MIX 30 ORTHODONTIC BONDING SYSTEM
K832112 · Scientific Pharmaceuticals, Inc. · Aug 1983
AUTO-TACH
K832291 · Dentsply Intl. · Aug 1983
CURAY-ECLIPSE VISIBLE LIGHT CURED ORTHO
K831495 · Scientific Pharmaceuticals, Inc. · Jul 1983