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FDA 510(k)

Straumann cerabone

K-Number: K173594 · 2018-10-19

ApplicantInstitut Straumann AG
Decision Date2018-10-19
Product CodeNPM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann cerabone 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 2018-10-19 under 510(k) number K173594. The device is classified under product code NPM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Straumann cerabone?

Straumann cerabone is a medical device that received FDA 510(k) clearance on 2018-10-19. The listed applicant is Institut Straumann AG. The 510(k) number is K173594.

When did Straumann cerabone receive FDA 510(k) clearance?

Straumann cerabone received FDA 510(k) clearance on 2018-10-19, under 510(k) number K173594.

Who is the listed applicant for Straumann cerabone?

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 cerabone?

The FDA product code for Straumann cerabone is NPM.

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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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