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FDA 510(k)

STRAUMANN ORTHOSYSTEM

K-Number: K060062 · 2006-02-03

ApplicantInstitut Straumann AG
Decision Date2006-02-03
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STRAUMANN ORTHOSYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Institut Straumann AG. It received FDA 510(k) clearance on 2006-02-03 under 510(k) number K060062. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRAUMANN ORTHOSYSTEM?

STRAUMANN ORTHOSYSTEM is a medical device that received FDA 510(k) clearance on 2006-02-03. The listed applicant is Institut Straumann AG. The 510(k) number is K060062.

When did STRAUMANN ORTHOSYSTEM receive FDA 510(k) clearance?

STRAUMANN ORTHOSYSTEM received FDA 510(k) clearance on 2006-02-03, under 510(k) number K060062.

Who is the listed applicant for STRAUMANN ORTHOSYSTEM?

The FDA 510(k) record lists Institut Straumann AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STRAUMANN ORTHOSYSTEM?

The FDA product code for STRAUMANN ORTHOSYSTEM is OAT.

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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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