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FDA 510(k)

STRAUMANN GBR SYSTEM

K-Number: K011698 · 2001-08-23

ApplicantInstitut Straumann AG
Decision Date2001-08-23
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STRAUMANN GBR SYSTEM 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 2001-08-23 under 510(k) number K011698. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRAUMANN GBR SYSTEM?

STRAUMANN GBR SYSTEM is a medical device that received FDA 510(k) clearance on 2001-08-23. The listed applicant is Institut Straumann AG. The 510(k) number is K011698.

When did STRAUMANN GBR SYSTEM receive FDA 510(k) clearance?

STRAUMANN GBR SYSTEM received FDA 510(k) clearance on 2001-08-23, under 510(k) number K011698.

Who is the listed applicant for STRAUMANN GBR SYSTEM?

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 GBR SYSTEM?

The FDA product code for STRAUMANN GBR SYSTEM is JEY.

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Other records listing Institut Straumann AG as applicant

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Related Devices (Code: JEY)

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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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