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FDA 510(k)

HI TECH IMPLANT, HT PHYSIO IMPLANT

K-Number: K091913 · 2009-10-30

ApplicantBy Dental Srl
Decision Date2009-10-30
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HI TECH IMPLANT, HT PHYSIO IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is By Dental Srl. It received FDA 510(k) clearance on 2009-10-30 under 510(k) number K091913. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HI TECH IMPLANT, HT PHYSIO IMPLANT?

HI TECH IMPLANT, HT PHYSIO IMPLANT is a medical device that received FDA 510(k) clearance on 2009-10-30. The listed applicant is By Dental Srl. The 510(k) number is K091913.

When did HI TECH IMPLANT, HT PHYSIO IMPLANT receive FDA 510(k) clearance?

HI TECH IMPLANT, HT PHYSIO IMPLANT received FDA 510(k) clearance on 2009-10-30, under 510(k) number K091913.

Who is the listed applicant for HI TECH IMPLANT, HT PHYSIO IMPLANT?

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

What is the FDA product code for HI TECH IMPLANT, HT PHYSIO IMPLANT?

The FDA product code for HI TECH IMPLANT, HT PHYSIO IMPLANT is EKX.

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Related Devices (Code: EKX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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