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FDA 510(k)

BONEFIT HOLLOW CYLINDER IMPLANTS

K-Number: K894593 · 1990-02-13

ApplicantInstitut Straumann AG
Decision Date1990-02-13
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BONEFIT HOLLOW CYLINDER IMPLANTS 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 1990-02-13 under 510(k) number K894593. 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 BONEFIT HOLLOW CYLINDER IMPLANTS?

BONEFIT HOLLOW CYLINDER IMPLANTS is a medical device that received FDA 510(k) clearance on 1990-02-13. The listed applicant is Institut Straumann AG. The 510(k) number is K894593.

When did BONEFIT HOLLOW CYLINDER IMPLANTS receive FDA 510(k) clearance?

BONEFIT HOLLOW CYLINDER IMPLANTS received FDA 510(k) clearance on 1990-02-13, under 510(k) number K894593.

Who is the listed applicant for BONEFIT HOLLOW CYLINDER IMPLANTS?

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 BONEFIT HOLLOW CYLINDER IMPLANTS?

The FDA product code for BONEFIT HOLLOW CYLINDER IMPLANTS is DZE.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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