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FDA 510(k)

GROOVY IMPLANTS

K-Number: K050258 · 2005-04-19

ApplicantNobel Biocare AB
Decision Date2005-04-19
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GROOVY IMPLANTS 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 2005-04-19 under 510(k) number K050258. 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 GROOVY IMPLANTS?

GROOVY IMPLANTS is a medical device that received FDA 510(k) clearance on 2005-04-19. The listed applicant is Nobel Biocare AB. The 510(k) number is K050258.

When did GROOVY IMPLANTS receive FDA 510(k) clearance?

GROOVY IMPLANTS received FDA 510(k) clearance on 2005-04-19, under 510(k) number K050258.

Who is the listed applicant for GROOVY IMPLANTS?

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 GROOVY IMPLANTS?

The FDA product code for GROOVY IMPLANTS 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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