Cleared Traditional

K840405 - BOSWORTH DENT-ALL

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

K840405 · Harry J. Bosworth Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K840405

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
Combination Product No
PCCP Authorized No
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.

EBI Device Classification - Class 2, Special Controls

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 217
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K840405.
AUSTENAL ACUPAC HI DENTURE BASE MATERIAL
K862558 · Austenal Dental, Inc. · Jul 1986
ACRYLIC SOLDER
K861239 · Parker Laboratories, Inc. · Apr 1986
CLEAR LINER
K842576 · Harry J. Bosworth Co. · Sep 1984
RESIL
K840548 · Parker Laboratories, Inc. · Apr 1984
DENTURE BASE RESIN
K834409 · Dentsply Intl. · Feb 1984
DENTURE RELINING, REPAIR/REBASING RESIN
K831647 · Dentsply Intl. · Jun 1983