FDA · official record K223340Substantially Equivalent

EDS Calculus Softener TURBO CR

Name: EDS Calculus Softener TURBO CR — FDA K223340
Creator: Essential Dental Systems, Inc.
Keywords: EDS Calculus Softener TURBO CR, EDS Calculus Softener TURBO CR, K223340, ELC, FDA

United StatesELCEssential Dental Systems, Inc.

Verified

Official record identity

FDA application number: K223340
Decision date: December 11, 2023
Published decision: Substantially Equivalent

Classification

Product code: ELC

Published parties

Applicant: Essential Dental Systems, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2022-11-01
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.4850

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.