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FDA 510(k)

DIAMONDCOAT ULTRASONIC INSERTS

K-Number: K030111 · 2003-02-07

ApplicantDentsply International
Decision Date2003-02-07
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIAMONDCOAT ULTRASONIC INSERTS is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply International. It received FDA 510(k) clearance on 2003-02-07 under 510(k) number K030111. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAMONDCOAT ULTRASONIC INSERTS?

DIAMONDCOAT ULTRASONIC INSERTS is a medical device that received FDA 510(k) clearance on 2003-02-07. The listed applicant is Dentsply International. The 510(k) number is K030111.

When did DIAMONDCOAT ULTRASONIC INSERTS receive FDA 510(k) clearance?

DIAMONDCOAT ULTRASONIC INSERTS received FDA 510(k) clearance on 2003-02-07, under 510(k) number K030111.

Who is the listed applicant for DIAMONDCOAT ULTRASONIC INSERTS?

The FDA 510(k) record lists Dentsply International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIAMONDCOAT ULTRASONIC INSERTS?

The FDA product code for DIAMONDCOAT ULTRASONIC INSERTS is ELC.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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