Straumann BLX Ø3.5 mm Implants
K-Number: K191256 · 2019-12-27
ApplicantInstitut Straumann AG
Decision Date2019-12-27
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Straumann BLX Ø3.5 mm Implants is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2019-12-27 under approval number K191256. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Straumann BLX Ø3.5 mm Implants?
Straumann BLX Ø3.5 mm Implants is a medical device that received FDA 510(k) clearance on 2019-12-27. It is manufactured by Institut Straumann AG. The 510(k) number is K191256.
When was Straumann BLX Ø3.5 mm Implants approved by the FDA?
Straumann BLX Ø3.5 mm Implants received FDA 510(k) clearance on 2019-12-27, under approval number K191256.
What company makes Straumann BLX Ø3.5 mm Implants?
Straumann BLX Ø3.5 mm Implants is manufactured by Institut Straumann AG.
What is the FDA product code for Straumann BLX Ø3.5 mm Implants?
The FDA product code for Straumann BLX Ø3.5 mm Implants is DZE.
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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.