Cleared Traditional

K100833 - SYLE SMARTIP

K100833 is an FDA 510(k) clearance for SYLE SMARTIP, manufactured by Osspray, Ltd.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K100833 · Osspray, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
71d
Days
Class 1
Risk

K100833 is an FDA 510(k) clearance for the SYLE SMARTIP. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Osspray, Ltd. (Gainesville, US). The FDA issued a Cleared decision on June 3, 2010 after a review of 71 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Osspray, Ltd. devices

FDA 510(k) Submission Details - K100833

510(k) Number K100833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2010
Decision Date June 03, 2010
Days to Decision 71 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 127d · This submission: 71d
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 104
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K100833.
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