EDS Calculus Softener TURBO CR
FDA 510(k) K223340 · Essential Dental Systems, Inc.
510(k) numberK223340
Submission
- Device name
- EDS Calculus Softener TURBO CR
- Applicant
- Essential Dental Systems, Inc.
South Hackensack, NJ, US - Received
- November 1, 2022
- Decision date
- December 11, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was EDS Calculus Softener TURBO CR cleared by the FDA?
EDS Calculus Softener TURBO CR (K223340) received a 510(k) decision of Substantially Equivalent on December 11, 2023, 405 days after the submission was received.
What is the product code of K223340?
The FDA product code is ELC – Scaler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 872.4850.