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FDA 510(k)

STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT

K-Number: K070307 · 2007-05-02

ApplicantDentsply International, Inc.
Decision Date2007-05-02
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply International, Inc.. It received FDA 510(k) clearance on 2007-05-02 under 510(k) number K070307. 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 HANDPIECE SLEEVE WITH LED LIGHT?

STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT is a medical device that received FDA 510(k) clearance on 2007-05-02. The listed applicant is Dentsply International, Inc.. The 510(k) number is K070307.

When did STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT receive FDA 510(k) clearance?

STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT received FDA 510(k) clearance on 2007-05-02, under 510(k) number K070307.

Who is the listed applicant for STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT?

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

What is the FDA product code for STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT?

The FDA product code for STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT 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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