Straumann TLX Novaloc and Cementable Abutments
K-Number: K203355 · 2021-02-12
ApplicantInstitut Straumann AG
Decision Date2021-02-12
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Straumann TLX Novaloc and Cementable Abutments is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2021-02-12 under approval number K203355. 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 TLX Novaloc and Cementable Abutments?
Straumann TLX Novaloc and Cementable Abutments is a medical device that received FDA 510(k) clearance on 2021-02-12. It is manufactured by Institut Straumann AG. The 510(k) number is K203355.
When was Straumann TLX Novaloc and Cementable Abutments approved by the FDA?
Straumann TLX Novaloc and Cementable Abutments received FDA 510(k) clearance on 2021-02-12, under approval number K203355.
What company makes Straumann TLX Novaloc and Cementable Abutments?
Straumann TLX Novaloc and Cementable Abutments is manufactured by Institut Straumann AG.
What is the FDA product code for Straumann TLX Novaloc and Cementable Abutments?
The FDA product code for Straumann TLX Novaloc and Cementable 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.