TIB Abutment System
K-Number: K193084 · 2020-10-27
ApplicantSouthern Implants (Pty), Ltd.
Decision Date2020-10-27
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
TIB Abutment System is a medical device manufactured by Southern Implants (Pty), Ltd.. It received FDA 510(k) clearance on 2020-10-27 under approval number K193084. 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 TIB Abutment System?
TIB Abutment System is a medical device that received FDA 510(k) clearance on 2020-10-27. It is manufactured by Southern Implants (Pty), Ltd.. The 510(k) number is K193084.
When was TIB Abutment System approved by the FDA?
TIB Abutment System received FDA 510(k) clearance on 2020-10-27, under approval number K193084.
What company makes TIB Abutment System?
TIB Abutment System is manufactured by Southern Implants (Pty), Ltd..
What is the FDA product code for TIB Abutment System?
The FDA product code for TIB Abutment System 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.