Cleared Traditional

K100731 - BOSWORTH AIR POLISHER

K100731 is the FDA 510(k) clearance for BOSWORTH AIR POLISHER by Harry J. Bosworth Co.. It is a Class 1 Dental device (product code EFB) cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K100731 · Harry J. Bosworth Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
263d
Days
Class 1
Risk

K100731 is an FDA 510(k) clearance for the BOSWORTH AIR POLISHER. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Harry J. Bosworth Co. (Skokie, US). The FDA issued a Cleared decision on December 3, 2010 after a review of 263 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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 K100731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2010
Decision Date December 03, 2010
Days to Decision 263 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 127d · This submission: 263d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EFB Handpiece, Air-powered, Dental

All 65
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K100731.
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K091065 · J. Morita USA, Inc. · Oct 2009
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K082716 · A-Dec, Inc. · Jan 2009