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FDA 510(k)

NOBELACTIVE 8.5 MM & 18.0 MM

K-Number: K083205 · 2009-02-13

ApplicantNobel Biocare AB
Decision Date2009-02-13
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NOBELACTIVE 8.5 MM & 18.0 MM 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 2009-02-13 under 510(k) number K083205. 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 NOBELACTIVE 8.5 MM & 18.0 MM?

NOBELACTIVE 8.5 MM & 18.0 MM is a medical device that received FDA 510(k) clearance on 2009-02-13. The listed applicant is Nobel Biocare AB. The 510(k) number is K083205.

When did NOBELACTIVE 8.5 MM & 18.0 MM receive FDA 510(k) clearance?

NOBELACTIVE 8.5 MM & 18.0 MM received FDA 510(k) clearance on 2009-02-13, under 510(k) number K083205.

Who is the listed applicant for NOBELACTIVE 8.5 MM & 18.0 MM?

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 NOBELACTIVE 8.5 MM & 18.0 MM?

The FDA product code for NOBELACTIVE 8.5 MM & 18.0 MM 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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