Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments
K-Number: K181703 · 2018-12-28
ApplicantInstitut Straumann AG
Decision Date2018-12-28
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2018-12-28 under approval number K181703. 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 Line Extension - Implants, SRAs and Anatomic Abutments?
Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments is a medical device that received FDA 510(k) clearance on 2018-12-28. It is manufactured by Institut Straumann AG. The 510(k) number is K181703.
When was Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments approved by the FDA?
Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments received FDA 510(k) clearance on 2018-12-28, under approval number K181703.
What company makes Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments?
Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments is manufactured by Institut Straumann AG.
What is the FDA product code for Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments?
The FDA product code for Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments 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.