Cleared Traditional

K070307 - STERI -MATE HANDPIECE SLEEVE WITH LED L...

K070307 is the FDA 510(k) clearance for STERI -MATE HANDPIECE SLEEVE WITH LED L... by Dentsply International, Inc.. It is a Class 2 Dental device (product code ELC) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K070307 · Dentsply International, Inc. · Dental device
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May 2007
Decision
90d
Days
Class 2
Risk

K070307 is an FDA 510(k) clearance for the STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Dentsply International, Inc. (York, US). The FDA issued a Cleared decision on May 2, 2007 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - 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 Dentsply International, Inc. devices

Submission Details

510(k) Number K070307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2007
Decision Date May 02, 2007
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELC Scaler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4850
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 - ELC Scaler, Ultrasonic

All 56
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