EDS Calculus Softener TURBO CR
K-Number: K223340 · 2023-12-11
ApplicantEssential Dental Systems, Inc.
Decision Date2023-12-11
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
EDS Calculus Softener TURBO CR is a medical device manufactured by Essential Dental Systems, Inc.. It received FDA 510(k) clearance on 2023-12-11 under approval number K223340. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EDS Calculus Softener TURBO CR?
EDS Calculus Softener TURBO CR is a medical device that received FDA 510(k) clearance on 2023-12-11. It is manufactured by Essential Dental Systems, Inc.. The 510(k) number is K223340.
When was EDS Calculus Softener TURBO CR approved by the FDA?
EDS Calculus Softener TURBO CR received FDA 510(k) clearance on 2023-12-11, under approval number K223340.
What company makes EDS Calculus Softener TURBO CR?
EDS Calculus Softener TURBO CR is manufactured by Essential Dental Systems, Inc..
What is the FDA product code for EDS Calculus Softener TURBO CR?
The FDA product code for EDS Calculus Softener TURBO CR is ELC.
Other Devices by Essential Dental Systems, Inc.
Related Devices (Code: ELC)
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.