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FDA 510(k)

NobelProcera HT ML Full Contour Zirconia Crown

K-Number: K153534 · 2016-06-06

Decision Date2016-06-06
Product CodeELL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NobelProcera HT ML Full Contour Zirconia Crown is a medical device manufactured by Nobel Biocare AB. It received FDA 510(k) clearance on 2016-06-06 under approval number K153534. 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 Full Contour Zirconia Crown?

NobelProcera HT ML Full Contour Zirconia Crown is a medical device that received FDA 510(k) clearance on 2016-06-06. It is manufactured by Nobel Biocare AB. The 510(k) number is K153534.

When was NobelProcera HT ML Full Contour Zirconia Crown approved by the FDA?

NobelProcera HT ML Full Contour Zirconia Crown received FDA 510(k) clearance on 2016-06-06, under approval number K153534.

What company makes NobelProcera HT ML Full Contour Zirconia Crown?

NobelProcera HT ML Full Contour Zirconia Crown is manufactured by Nobel Biocare AB.

What is the FDA product code for NobelProcera HT ML Full Contour Zirconia Crown?

The FDA product code for NobelProcera HT ML Full Contour Zirconia Crown 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.