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FDA 510(k)

NOBELPROCERA IPS E.MAX CROWN

K-Number: K100512 · 2010-08-20

ApplicantNobel Biocare AB
Decision Date2010-08-20
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NOBELPROCERA IPS E.MAX CROWN 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 2010-08-20 under 510(k) number K100512. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOBELPROCERA IPS E.MAX CROWN?

NOBELPROCERA IPS E.MAX CROWN is a medical device that received FDA 510(k) clearance on 2010-08-20. The listed applicant is Nobel Biocare AB. The 510(k) number is K100512.

When did NOBELPROCERA IPS E.MAX CROWN receive FDA 510(k) clearance?

NOBELPROCERA IPS E.MAX CROWN received FDA 510(k) clearance on 2010-08-20, under 510(k) number K100512.

Who is the listed applicant for NOBELPROCERA IPS E.MAX CROWN?

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 NOBELPROCERA IPS E.MAX CROWN?

The FDA product code for NOBELPROCERA IPS E.MAX CROWN is EIH.

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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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