SMARTbase Abutment System
K-Number: K223535 · 2023-06-20
Decision Date2023-06-20
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
SMARTbase Abutment System is a medical device manufactured by Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2023-06-20 under approval number K223535. 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 SMARTbase Abutment System?
SMARTbase Abutment System is a medical device that received FDA 510(k) clearance on 2023-06-20. It is manufactured by Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K223535.
When was SMARTbase Abutment System approved by the FDA?
SMARTbase Abutment System received FDA 510(k) clearance on 2023-06-20, under approval number K223535.
What company makes SMARTbase Abutment System?
SMARTbase Abutment System is manufactured by Implant Direct Sybron Manufacturing, LLC.
What is the FDA product code for SMARTbase Abutment System?
The FDA product code for SMARTbase Abutment System is NHA.
Related Clinical Trials
Other Devices by Implant Direct Sybron Manufacturing, LLC
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K160786RODO Abutment SystemRodo Medical, Inc.
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.