TLX SRAs and TLX Gold Abutments
K-Number: K213063 · 2022-04-08
ApplicantInstitut Straumann AG
Decision Date2022-04-08
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
TLX SRAs and TLX Gold Abutments is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2022-04-08 under approval number K213063. 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 TLX SRAs and TLX Gold Abutments?
TLX SRAs and TLX Gold Abutments is a medical device that received FDA 510(k) clearance on 2022-04-08. It is manufactured by Institut Straumann AG. The 510(k) number is K213063.
When was TLX SRAs and TLX Gold Abutments approved by the FDA?
TLX SRAs and TLX Gold Abutments received FDA 510(k) clearance on 2022-04-08, under approval number K213063.
What company makes TLX SRAs and TLX Gold Abutments?
TLX SRAs and TLX Gold Abutments is manufactured by Institut Straumann AG.
What is the FDA product code for TLX SRAs and TLX Gold Abutments?
The FDA product code for TLX SRAs and TLX Gold 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.