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FDA 510(k)

IQ IMPLANTS; IQ IMPLANTS; IQ IMPLANTS ABUTMENTS

K-Number: K130829 · 2013-11-14

Decision Date2013-11-14
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IQ IMPLANTS; IQ IMPLANTS; IQ IMPLANTS ABUTMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Iq Implants , Ltd.. It received FDA 510(k) clearance on 2013-11-14 under 510(k) number K130829. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IQ IMPLANTS; IQ IMPLANTS; IQ IMPLANTS ABUTMENTS?

IQ IMPLANTS; IQ IMPLANTS; IQ IMPLANTS ABUTMENTS is a medical device that received FDA 510(k) clearance on 2013-11-14. The listed applicant is Iq Implants , Ltd.. The 510(k) number is K130829.

When did IQ IMPLANTS; IQ IMPLANTS; IQ IMPLANTS ABUTMENTS receive FDA 510(k) clearance?

IQ IMPLANTS; IQ IMPLANTS; IQ IMPLANTS ABUTMENTS received FDA 510(k) clearance on 2013-11-14, under 510(k) number K130829.

Who is the listed applicant for IQ IMPLANTS; IQ IMPLANTS; IQ IMPLANTS ABUTMENTS?

The FDA 510(k) record lists Iq Implants , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IQ IMPLANTS; IQ IMPLANTS; IQ IMPLANTS ABUTMENTS?

The FDA product code for IQ IMPLANTS; IQ IMPLANTS; IQ IMPLANTS ABUTMENTS is DZE.

Related Clinical Trials

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.

Related Devices (Code: DZE)

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.

Official Source

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