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Ultrasonic Tips with Diamond Coating

by Sybron Endo/Analytic

510(k) K021253

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK021253 Date5 Jul 2002ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ELC
Device Class
Class II
Regulation
21 CFR Part 872.4850
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Ultrasonic tips with diamond coating are dental instruments designed to improve cutting efficiency and precision in endodontic procedures. They are utilized in endodontic root preparation procedures, including retro-prep of root ends.

These devices were cleared via the FDA 510(k) pathway on July 5, 2002, and are classified as Class 2 devices under product code ELC. They are supplied as non-sterile, reusable instruments for use in dental settings.

Other devices from Sybron Endo/Analytic

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are ultrasonic tips with diamond coating used for?

    Ultrasonic tips with diamond coating are dental instruments designed to improve cutting efficiency and precision in endodontic procedures, specifically utilized in endodontic root preparation procedures including retro-prep of root ends.

  • How are ultrasonic tips with diamond coating supplied and are they sterile?

    These devices are supplied as non-sterile, reusable instruments for use in dental settings, meaning they require cleaning and sterilization by the user before each use.

  • What regulatory pathway cleared the ultrasonic tips with diamond coating and when?

    These devices were cleared via the FDA 510(k) pathway on July 5, 2002, under submission number K021253, and are classified as Class 2 devices under product code ELC.