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FDA 510(k)

ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES

K-Number: K123139 · 2013-03-28

ApplicantAsi Medical, Inc.
Decision Date2013-03-28
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Asi Medical, Inc.. It received FDA 510(k) clearance on 2013-03-28 under 510(k) number K123139. 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 ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES?

ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES is a medical device that received FDA 510(k) clearance on 2013-03-28. The listed applicant is Asi Medical, Inc.. The 510(k) number is K123139.

When did ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES receive FDA 510(k) clearance?

ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES received FDA 510(k) clearance on 2013-03-28, under 510(k) number K123139.

Who is the listed applicant for ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES?

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

What is the FDA product code for ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES?

The FDA product code for ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES is ELC.

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Official Source

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

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