Cleared Traditional

K021253 - ULTRASONIC TIPS WITH DIAMOND COATING

K021253 is an FDA 510(k) clearance for ULTRASONIC TIPS WITH DIAMOND COATING, manufactured by Sybron Endo/Analytic. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K021253 · Sybron Endo/Analytic · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
77d
Days
Class 2
Risk

K021253 is an FDA 510(k) clearance for the ULTRASONIC TIPS WITH DIAMOND COATING. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Sybron Endo/Analytic (Orange, US). The FDA issued a Cleared decision on July 5, 2002 after a review of 77 days - a notably fast clearance 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: 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 Sybron Endo/Analytic devices

FDA 510(k) Submission Details - K021253

510(k) Number K021253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2002
Decision Date July 05, 2002
Days to Decision 77 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
50d faster than avg
Panel avg: 127d · This submission: 77d
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 106
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K021253.
CARRIER TIPS
K031461 · Dentsply Intl. · Aug 2003
DIAMONDCOAT ULTRASONIC INSERTS
K030111 · Dentsply International · Feb 2003
STERI-MATE STERILIZABLE HANDPIECE
K023697 · Dentsply International · Nov 2002
PREMIER ULTRASONIC SCALER AND INSERTS
K010195 · Premier Dental Products Co. · Apr 2001
VECTOR
K002122 · Air Techniques, Inc. · Dec 2000
ART-M3 25K, MODEL M3-1-ART2-A1
K994203 · Bonart Co., Ltd. · Mar 2000