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FDA 510(k)

Straumann PUREloc abutments

K-Number: K192029 · 2019-10-28

ApplicantInstitut Straumann AG
Decision Date2019-10-28
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann PUREloc abutments 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 2019-10-28 under 510(k) number K192029. 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 PUREloc abutments?

Straumann PUREloc abutments is a medical device that received FDA 510(k) clearance on 2019-10-28. The listed applicant is Institut Straumann AG. The 510(k) number is K192029.

When did Straumann PUREloc abutments receive FDA 510(k) clearance?

Straumann PUREloc abutments received FDA 510(k) clearance on 2019-10-28, under 510(k) number K192029.

Who is the listed applicant for Straumann PUREloc abutments?

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 PUREloc abutments?

The FDA product code for Straumann PUREloc abutments is NHA.

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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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