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 a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2019-10-28 under approval 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. It is manufactured by Institut Straumann AG. The 510(k) number is K192029.
When was Straumann PUREloc abutments approved by the FDA?
Straumann PUREloc abutments received FDA 510(k) clearance on 2019-10-28, under approval number K192029.
What company makes Straumann PUREloc abutments?
Straumann PUREloc abutments is manufactured by Institut Straumann AG.
What is the FDA product code for Straumann PUREloc abutments?
The FDA product code for Straumann PUREloc abutments 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.