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FDA 510(k)

SFB & CFB IMPLANTS

K-Number: K061003 · 2006-06-30

ApplicantNobel Biocare AB
Decision Date2006-06-30
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SFB & CFB 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 2006-06-30 under 510(k) number K061003. 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 SFB & CFB IMPLANTS?

SFB & CFB IMPLANTS is a medical device that received FDA 510(k) clearance on 2006-06-30. The listed applicant is Nobel Biocare AB. The 510(k) number is K061003.

When did SFB & CFB IMPLANTS receive FDA 510(k) clearance?

SFB & CFB IMPLANTS received FDA 510(k) clearance on 2006-06-30, under 510(k) number K061003.

Who is the listed applicant for SFB & CFB 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 SFB & CFB IMPLANTS?

The FDA product code for SFB & CFB 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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