Southern Implants PEEK Abutments
K-Number: K172160 · 2018-02-09
ApplicantSouthern Implants (Pty), Ltd.
Decision Date2018-02-09
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Southern Implants PEEK Abutments is a medical device manufactured by Southern Implants (Pty), Ltd.. It received FDA 510(k) clearance on 2018-02-09 under approval number K172160. 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 Southern Implants PEEK Abutments?
Southern Implants PEEK Abutments is a medical device that received FDA 510(k) clearance on 2018-02-09. It is manufactured by Southern Implants (Pty), Ltd.. The 510(k) number is K172160.
When was Southern Implants PEEK Abutments approved by the FDA?
Southern Implants PEEK Abutments received FDA 510(k) clearance on 2018-02-09, under approval number K172160.
What company makes Southern Implants PEEK Abutments?
Southern Implants PEEK Abutments is manufactured by Southern Implants (Pty), Ltd..
What is the FDA product code for Southern Implants PEEK Abutments?
The FDA product code for Southern Implants PEEK Abutments is NHA.
Related Clinical Trials
Other Devices by Southern Implants (Pty), Ltd.
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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.