Cleared Traditional

K100731 - BOSWORTH AIR POLISHER

K100731 is an FDA 510(k) clearance for BOSWORTH AIR POLISHER, manufactured by Harry J. Bosworth Co.. The device is a Class 1 Dental device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K100731

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
135d slower than avg
Panel avg: 128d · This submission: 263d
Pathway characteristics
Predicate-based equivalence.

EFB Device Classification - Class 1, General Controls

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 249
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K100731.
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K100731 · BOSWORTH AIR POLISHER
Download PDF FDA Summary Harry J. Bosworth Co.