Cleared Traditional

K842448 - BOSWORTH SUPER BOND DENTAL ADHESIVE

K842448 is the FDA 510(k) clearance for BOSWORTH SUPER BOND DENTAL ADHESIVE by Harry J. Bosworth Co.. It is a Class 2 Dental device (product code DYH) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K842448 · Harry J. Bosworth Co. · Dental device
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Sep 1984
Decision
97d
Days
Class 2
Risk

K842448 is an FDA 510(k) clearance for the BOSWORTH SUPER BOND DENTAL ADHESIVE. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Harry J. Bosworth Co. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1984 after a review of 97 days - within the typical 510(k) review window.

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 Harry J. Bosworth Co. devices

Submission Details

510(k) Number K842448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1984
Decision Date September 27, 1984
Days to Decision 97 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 127d · This submission: 97d
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 68
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K842448.
ESPE NIMETIC-GRIP
K844844 · Espe GmbH (Us) · Feb 1986
EXCEL BRACKET ADHESIVE
K854050 · Johnson & Johnson Professionals, Inc. · Nov 1985
VISIBLE LIGHT CURED ORTHODONTIC ADHESIVE
K853523 · Dentsply Intl. · Nov 1985
SOLO-TACH
K832292 · Dentsply Intl. · Sep 1983
NO-MIX 30 ORTHODONTIC BONDING SYSTEM
K832112 · Scientific Pharmaceuticals, Inc. · Aug 1983
AUTO-TACH
K832291 · Dentsply Intl. · Aug 1983