Cleared Traditional

K842448 - BOSWORTH SUPER BOND DENTAL ADHESIVE

K842448 is an FDA 510(k) clearance for BOSWORTH SUPER BOND DENTAL ADHESIVE, manufactured by Harry J. Bosworth Co.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K842448

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
Combination Product No
PCCP Authorized No
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.

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 136
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K842448.
VISIBLE LIGHT CURED ORTHODONTIC ADHESIVE
K853523 · Dentsply Intl. · Nov 1985
CLEANSE N BOND I
K844133 · Lee Pharmaceuticals · Jan 1985
CLEANSE N BOND II
K844134 · Lee Pharmaceuticals · Jan 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