Cleared Traditional

K840405 - BOSWORTH DENT-ALL

K840405 is the FDA 510(k) clearance for BOSWORTH DENT-ALL by Harry J. Bosworth Co.. It is a Class 2 Dental device (product code EBI) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K840405 · Harry J. Bosworth Co. · Dental device
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May 1984
Decision
91d
Days
Class 2
Risk

K840405 is an FDA 510(k) clearance for the BOSWORTH DENT-ALL. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Harry J. Bosworth Co. (Mchenry, US). The FDA issued a Cleared decision on May 1, 1984 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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 K840405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1984
Decision Date May 01, 1984
Days to Decision 91 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 127d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 129
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K840405.
CURAY-FORM
K895222 · Scientific Pharmaceuticals, Inc. · Oct 1989
TRIAD ORTHODONTIC GEL
K882482 · Dentsply Intl. · Aug 1988
TRIAD IMPACT
K863324 · Dentsply Intl. · Sep 1986
DENTURE BASE RESIN
K834409 · Dentsply Intl. · Feb 1984
DENTURE RELINING, REPAIR/REBASING RESIN
K831647 · Dentsply Intl. · Jun 1983
MAXUM DENTURE RESIN
K800400 · Dentsply Intl. · Mar 1980