Dentalis Bio Solution Implants
K-Number: K161281 · 2017-01-11
ApplicantDentalis Bio Solution Implants, LLC
Decision Date2017-01-11
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Dentalis Bio Solution Implants is a medical device manufactured by Dentalis Bio Solution Implants, LLC. It received FDA 510(k) clearance on 2017-01-11 under approval number K161281. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Dentalis Bio Solution Implants?
Dentalis Bio Solution Implants is a medical device that received FDA 510(k) clearance on 2017-01-11. It is manufactured by Dentalis Bio Solution Implants, LLC. The 510(k) number is K161281.
When was Dentalis Bio Solution Implants approved by the FDA?
Dentalis Bio Solution Implants received FDA 510(k) clearance on 2017-01-11, under approval number K161281.
What company makes Dentalis Bio Solution Implants?
Dentalis Bio Solution Implants is manufactured by Dentalis Bio Solution Implants, LLC.
What is the FDA product code for Dentalis Bio Solution Implants?
The FDA product code for Dentalis Bio Solution Implants is DZE.
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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.