MIS Ti-base Abutment
K-Number: K191152 · 2020-07-06
ApplicantDentsply Sirona
Decision Date2020-07-06
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
MIS Ti-base Abutment is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2020-07-06 under approval number K191152. 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 MIS Ti-base Abutment?
MIS Ti-base Abutment is a medical device that received FDA 510(k) clearance on 2020-07-06. It is manufactured by Dentsply Sirona. The 510(k) number is K191152.
When was MIS Ti-base Abutment approved by the FDA?
MIS Ti-base Abutment received FDA 510(k) clearance on 2020-07-06, under approval number K191152.
What company makes MIS Ti-base Abutment?
MIS Ti-base Abutment is manufactured by Dentsply Sirona.
What is the FDA product code for MIS Ti-base Abutment?
The FDA product code for MIS Ti-base Abutment is NHA.
Other Devices by Dentsply Sirona
Related Devices (Code: NHA)
K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.
K160798IPS e.max® Press Abutment Solutions for Viteo Base TiIvoclar Vivadent, AG
K162004PREMIUM Implant Systems SHELTA Implant SystemsSweden & Martina S.P.A.
K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd.
K161435Temporary Snap AbutmentNobel Biocare AB
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.