s-Clean Pre-Milled Abutment Mini
K-Number: K210410 · 2021-09-10
ApplicantDentis Co., Ltd.
Decision Date2021-09-10
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
s-Clean Pre-Milled Abutment Mini is a medical device manufactured by Dentis Co., Ltd.. It received FDA 510(k) clearance on 2021-09-10 under approval number K210410. 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 s-Clean Pre-Milled Abutment Mini?
s-Clean Pre-Milled Abutment Mini is a medical device that received FDA 510(k) clearance on 2021-09-10. It is manufactured by Dentis Co., Ltd.. The 510(k) number is K210410.
When was s-Clean Pre-Milled Abutment Mini approved by the FDA?
s-Clean Pre-Milled Abutment Mini received FDA 510(k) clearance on 2021-09-10, under approval number K210410.
What company makes s-Clean Pre-Milled Abutment Mini?
s-Clean Pre-Milled Abutment Mini is manufactured by Dentis Co., Ltd..
What is the FDA product code for s-Clean Pre-Milled Abutment Mini?
The FDA product code for s-Clean Pre-Milled Abutment Mini is NHA.
Other Devices by Dentis Co., Ltd.
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.