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FDA 510(k)

STERI-MATE STERILIZABLE HANDPIECE

K-Number: K023697 · 2002-11-06

ApplicantDentsply International
Decision Date2002-11-06
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STERI-MATE STERILIZABLE HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply International. It received FDA 510(k) clearance on 2002-11-06 under 510(k) number K023697. 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 STERI-MATE STERILIZABLE HANDPIECE?

STERI-MATE STERILIZABLE HANDPIECE is a medical device that received FDA 510(k) clearance on 2002-11-06. The listed applicant is Dentsply International. The 510(k) number is K023697.

When did STERI-MATE STERILIZABLE HANDPIECE receive FDA 510(k) clearance?

STERI-MATE STERILIZABLE HANDPIECE received FDA 510(k) clearance on 2002-11-06, under 510(k) number K023697.

Who is the listed applicant for STERI-MATE STERILIZABLE HANDPIECE?

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 STERI-MATE STERILIZABLE HANDPIECE?

The FDA product code for STERI-MATE STERILIZABLE HANDPIECE 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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