Straumann BLX Gold Abutments
K-Number: K200597 · 2020-08-19
Decision Date2020-08-19
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Straumann BLX Gold Abutments is a medical device manufactured by Straumann USA, LLC (On Behalf of Institut Straumann Ag). It received FDA 510(k) clearance on 2020-08-19 under approval number K200597. 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 BLX Gold Abutments?
Straumann BLX Gold Abutments is a medical device that received FDA 510(k) clearance on 2020-08-19. It is manufactured by Straumann USA, LLC (On Behalf of Institut Straumann Ag). The 510(k) number is K200597.
When was Straumann BLX Gold Abutments approved by the FDA?
Straumann BLX Gold Abutments received FDA 510(k) clearance on 2020-08-19, under approval number K200597.
What company makes Straumann BLX Gold Abutments?
Straumann BLX Gold Abutments is manufactured by Straumann USA, LLC (On Behalf of Institut Straumann Ag).
What is the FDA product code for Straumann BLX Gold Abutments?
The FDA product code for Straumann BLX Gold Abutments is NHA.
Other Devices by Straumann USA, LLC (On Behalf of Institut Straumann Ag)
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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.