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Diamondcoat Ultrasonic Inserts

by Dentsply International

510(k) K030111

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 · Special NumberK030111 Date7 Feb 2003ClearedStatusActive

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  • Withdrawn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, 23 Sep 2026

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

Diamondcoat Ultrasonic Inserts are dental scaler inserts designed for use in ultrasonic dental instruments. They are manufactured by Dentsply International and are intended for dental procedures requiring ultrasonic scaling.

The device is supplied as a Class II medical device with FDA 510(k) clearance (K030111) and is regulated under product code ELC. The inserts are available in various model numbers as listed in the device specifications, and are manufactured in York, PA.

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Questions

AI-generated answers, 23 Sep 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 Diamondcoat Ultrasonic Inserts used for?

    Diamondcoat Ultrasonic Inserts are dental scaler inserts designed for use in ultrasonic dental instruments. They are intended for dental procedures requiring ultrasonic scaling to remove plaque, calculus, and stains from teeth.

  • How are Diamondcoat Ultrasonic Inserts supplied?

    The inserts are supplied as a Class II medical device with FDA 510(k) clearance (K030111) and are regulated under product code ELC. They are manufactured in York, PA by Dentsply International and are available in various model numbers as specified in the device specifications.

  • What is the regulatory status of Diamondcoat Ultrasonic Inserts?

    Diamondcoat Ultrasonic Inserts have FDA 510(k) clearance with K number K030111. They are classified as a Class II medical device under product code ELC and were determined to be substantially equivalent to predicate devices through the special clearance process.

  • Are there different models of Diamondcoat Ultrasonic Inserts available?

    Yes, Diamondcoat Ultrasonic Inserts are available in various model numbers as listed in the device specifications. The specific model numbers can be found in the openfda data associated with the device, which includes numerous FEI numbers and registration numbers for different configurations.