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FDA 510(k)

CLS-2000 UNIT

K-Number: K024133 · 2003-10-01

ApplicantDentsply Intl.
Decision Date2003-10-01
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CLS-2000 UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 2003-10-01 under 510(k) number K024133. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLS-2000 UNIT?

CLS-2000 UNIT is a medical device that received FDA 510(k) clearance on 2003-10-01. The listed applicant is Dentsply Intl.. The 510(k) number is K024133.

When did CLS-2000 UNIT receive FDA 510(k) clearance?

CLS-2000 UNIT received FDA 510(k) clearance on 2003-10-01, under 510(k) number K024133.

Who is the listed applicant for CLS-2000 UNIT?

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

What is the FDA product code for CLS-2000 UNIT?

The FDA product code for CLS-2000 UNIT is FLE.

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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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