Cleared Traditional

K930698 - THE MODEL 3003 SCALER

K930698 is an FDA 510(k) clearance for THE MODEL 3003 SCALER, manufactured by Dentsply Intl.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K930698 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
162d
Days
Class 2
Risk

K930698 is an FDA 510(k) clearance for the THE MODEL 3003 SCALER. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on July 22, 1993 after a review of 162 days - an extended review cycle.

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 Intl. devices

FDA 510(k) Submission Details - K930698

510(k) Number K930698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1993
Decision Date July 22, 1993
Days to Decision 162 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
35d slower than avg
Panel avg: 127d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELC Device Classification - Class 2, Special Controls

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 136
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