FDA · official record K103498Substantially Equivalent

LAKONG ULTRASONIC SCALER

Name: LAKONG ULTRASONIC SCALER — FDA K103498
Creator: Lakong Medical Device Company, Ltd.
Keywords: LAKONG ULTRASONIC SCALER, LAKONG ULTRASONIC SCALER, K103498, ELC, FDA

United StatesELCLakong Medical Device Company, Ltd.

Verified

Official record identity

FDA application number: K103498
Decision date: March 31, 2011
Published decision: Substantially Equivalent

Classification

Product code: ELC

Published parties

Applicant: Lakong Medical Device Company, Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2010-11-29
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.