FDA · official record K201317Substantially Equivalent

TTBIO EVOCLEAN Ultrasonic Scaler

Name: TTBIO EVOCLEAN Ultrasonic Scaler — FDA K201317
Creator: Ttbio Corp.
Keywords: TTBIO EVOCLEAN Ultrasonic Scaler, TTBIO EVOCLEAN Ultrasonic Scaler, K201317, ELC, FDA

United StatesELCTtbio Corp.

Verified

Official record identity

FDA application number: K201317
Decision date: December 04, 2020
Published decision: Substantially Equivalent

Classification

Product code: ELC

Published parties

Applicant: Ttbio Corp.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2020-05-18
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.