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FDA 510(k)

CARBON FIBER BRIDGE, MODEL 28757

K-Number: K031070 · 2003-07-03

ApplicantNobel Biocare AB
Decision Date2003-07-03
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CARBON FIBER BRIDGE, MODEL 28757 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 2003-07-03 under 510(k) number K031070. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARBON FIBER BRIDGE, MODEL 28757?

CARBON FIBER BRIDGE, MODEL 28757 is a medical device that received FDA 510(k) clearance on 2003-07-03. The listed applicant is Nobel Biocare AB. The 510(k) number is K031070.

When did CARBON FIBER BRIDGE, MODEL 28757 receive FDA 510(k) clearance?

CARBON FIBER BRIDGE, MODEL 28757 received FDA 510(k) clearance on 2003-07-03, under 510(k) number K031070.

Who is the listed applicant for CARBON FIBER BRIDGE, MODEL 28757?

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 CARBON FIBER BRIDGE, MODEL 28757?

The FDA product code for CARBON FIBER BRIDGE, MODEL 28757 is EBI.

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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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