Straumann BLX Variobase Abutment
K-Number: K190082 · 2019-04-17
ApplicantInstitut Straumann AG
Decision Date2019-04-17
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Straumann BLX Variobase Abutment is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2019-04-17 under approval number K190082. 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 BLX Variobase Abutment?
Straumann BLX Variobase Abutment is a medical device that received FDA 510(k) clearance on 2019-04-17. It is manufactured by Institut Straumann AG. The 510(k) number is K190082.
When was Straumann BLX Variobase Abutment approved by the FDA?
Straumann BLX Variobase Abutment received FDA 510(k) clearance on 2019-04-17, under approval number K190082.
What company makes Straumann BLX Variobase Abutment?
Straumann BLX Variobase Abutment is manufactured by Institut Straumann AG.
What is the FDA product code for Straumann BLX Variobase Abutment?
The FDA product code for Straumann BLX Variobase Abutment 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.