Straumann BLX Line Extension - New Abutments
K-Number: K190040 · 2019-04-08
ApplicantInstitut Straumann AG
Decision Date2019-04-08
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Straumann BLX Line Extension - New Abutments is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2019-04-08 under approval number K190040. 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 Line Extension - New Abutments?
Straumann BLX Line Extension - New Abutments is a medical device that received FDA 510(k) clearance on 2019-04-08. It is manufactured by Institut Straumann AG. The 510(k) number is K190040.
When was Straumann BLX Line Extension - New Abutments approved by the FDA?
Straumann BLX Line Extension - New Abutments received FDA 510(k) clearance on 2019-04-08, under approval number K190040.
What company makes Straumann BLX Line Extension - New Abutments?
Straumann BLX Line Extension - New Abutments is manufactured by Institut Straumann AG.
What is the FDA product code for Straumann BLX Line Extension - New Abutments?
The FDA product code for Straumann BLX Line Extension - New 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.