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FDA 510(k)

MOLAR IMPLANT

K-Number: K081128 · 2008-11-07

ApplicantNobel Biocare AB
Decision Date2008-11-07
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MOLAR IMPLANT 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 2008-11-07 under 510(k) number K081128. 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 MOLAR IMPLANT?

MOLAR IMPLANT is a medical device that received FDA 510(k) clearance on 2008-11-07. The listed applicant is Nobel Biocare AB. The 510(k) number is K081128.

When did MOLAR IMPLANT receive FDA 510(k) clearance?

MOLAR IMPLANT received FDA 510(k) clearance on 2008-11-07, under 510(k) number K081128.

Who is the listed applicant for MOLAR IMPLANT?

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 MOLAR IMPLANT?

The FDA product code for MOLAR IMPLANT is 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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