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FDA 510(k)

n!ce Glass Ceramic Blocks for Amann Girrbach

K-Number: K170420 · 2017-03-02

ApplicantInstitut Straumann AG
Decision Date2017-03-02
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

n!ce Glass Ceramic Blocks for Amann Girrbach 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 2017-03-02 under 510(k) number K170420. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the n!ce Glass Ceramic Blocks for Amann Girrbach?

n!ce Glass Ceramic Blocks for Amann Girrbach is a medical device that received FDA 510(k) clearance on 2017-03-02. The listed applicant is Institut Straumann AG. The 510(k) number is K170420.

When did n!ce Glass Ceramic Blocks for Amann Girrbach receive FDA 510(k) clearance?

n!ce Glass Ceramic Blocks for Amann Girrbach received FDA 510(k) clearance on 2017-03-02, under 510(k) number K170420.

Who is the listed applicant for n!ce Glass Ceramic Blocks for Amann Girrbach?

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 n!ce Glass Ceramic Blocks for Amann Girrbach?

The FDA product code for n!ce Glass Ceramic Blocks for Amann Girrbach is EIH.

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Related Devices (Code: EIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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