FDA 510(k)

NobelProcera HT ML FCZ Bridge

K-Number: K162043 · 2016-11-22

Decision Date2016-11-22

Product CodeELL

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

NobelProcera HT ML FCZ Bridge is a medical device manufactured by Nobel Biocare AB. It received FDA 510(k) clearance on 2016-11-22 under approval number K162043. The device is classified under product code ELL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NobelProcera HT ML FCZ Bridge?

NobelProcera HT ML FCZ Bridge is a medical device that received FDA 510(k) clearance on 2016-11-22. It is manufactured by Nobel Biocare AB. The 510(k) number is K162043.

When was NobelProcera HT ML FCZ Bridge approved by the FDA?

NobelProcera HT ML FCZ Bridge received FDA 510(k) clearance on 2016-11-22, under approval number K162043.

What company makes NobelProcera HT ML FCZ Bridge?

NobelProcera HT ML FCZ Bridge is manufactured by Nobel Biocare AB.

What is the FDA product code for NobelProcera HT ML FCZ Bridge?

The FDA product code for NobelProcera HT ML FCZ Bridge is ELL.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.