s-Clean Pre-Milled Abutment
K-Number: K210362 · 2021-08-19
ApplicantDentis Co., Ltd.
Decision Date2021-08-19
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
s-Clean Pre-Milled Abutment is a medical device manufactured by Dentis Co., Ltd.. It received FDA 510(k) clearance on 2021-08-19 under approval number K210362. 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?
s-Clean Pre-Milled Abutment is a medical device that received FDA 510(k) clearance on 2021-08-19. It is manufactured by Dentis Co., Ltd.. The 510(k) number is K210362.
When was s-Clean Pre-Milled Abutment approved by the FDA?
s-Clean Pre-Milled Abutment received FDA 510(k) clearance on 2021-08-19, under approval number K210362.
What company makes s-Clean Pre-Milled Abutment?
s-Clean Pre-Milled Abutment is manufactured by Dentis Co., Ltd..
What is the FDA product code for s-Clean Pre-Milled Abutment?
The FDA product code for s-Clean Pre-Milled Abutment is NHA.
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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.