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FDA 510(k)

ZYGOMA IMPLANT (IMMEDIATE FUNCTION)

K-Number: K070182 · 2007-04-04

ApplicantNobel Biocare AB
Decision Date2007-04-04
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZYGOMA IMPLANT (IMMEDIATE FUNCTION) is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare AB. It received FDA 510(k) clearance on 2007-04-04 under 510(k) number K070182. 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 ZYGOMA IMPLANT (IMMEDIATE FUNCTION)?

ZYGOMA IMPLANT (IMMEDIATE FUNCTION) is a medical device that received FDA 510(k) clearance on 2007-04-04. The listed applicant is Nobel Biocare AB. The 510(k) number is K070182.

When did ZYGOMA IMPLANT (IMMEDIATE FUNCTION) receive FDA 510(k) clearance?

ZYGOMA IMPLANT (IMMEDIATE FUNCTION) received FDA 510(k) clearance on 2007-04-04, under 510(k) number K070182.

Who is the listed applicant for ZYGOMA IMPLANT (IMMEDIATE FUNCTION)?

The FDA 510(k) record lists Nobel Biocare AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZYGOMA IMPLANT (IMMEDIATE FUNCTION)?

The FDA product code for ZYGOMA IMPLANT (IMMEDIATE FUNCTION) is DZE.

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Related Devices (Code: DZE)

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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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