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FDA 510(k)

Straumann n!ce Glass Ceramic A14 Blocks

K-Number: K171773 · 2017-12-01

ApplicantInstitut Straumann AG
Decision Date2017-12-01
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann n!ce Glass Ceramic A14 Blocks 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 2017-12-01 under 510(k) number K171773. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Straumann n!ce Glass Ceramic A14 Blocks?

Straumann n!ce Glass Ceramic A14 Blocks is a medical device that received FDA 510(k) clearance on 2017-12-01. The listed applicant is Institut Straumann AG. The 510(k) number is K171773.

When did Straumann n!ce Glass Ceramic A14 Blocks receive FDA 510(k) clearance?

Straumann n!ce Glass Ceramic A14 Blocks received FDA 510(k) clearance on 2017-12-01, under 510(k) number K171773.

Who is the listed applicant for Straumann n!ce Glass Ceramic A14 Blocks?

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 n!ce Glass Ceramic A14 Blocks?

The FDA product code for Straumann n!ce Glass Ceramic A14 Blocks is NHA.

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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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