Straumann® BLC and TLC Implants
K-Number: K230108 · 2023-09-14
ApplicantInstitut Straumann AG
Decision Date2023-09-14
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Straumann® BLC and TLC Implants is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2023-09-14 under approval number K230108. 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® BLC and TLC Implants?
Straumann® BLC and TLC Implants is a medical device that received FDA 510(k) clearance on 2023-09-14. It is manufactured by Institut Straumann AG. The 510(k) number is K230108.
When was Straumann® BLC and TLC Implants approved by the FDA?
Straumann® BLC and TLC Implants received FDA 510(k) clearance on 2023-09-14, under approval number K230108.
What company makes Straumann® BLC and TLC Implants?
Straumann® BLC and TLC Implants is manufactured by Institut Straumann AG.
What is the FDA product code for Straumann® BLC and TLC Implants?
The FDA product code for Straumann® BLC and TLC 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.