FDA · official record K211531Substantially Equivalent

Cordless Prophy System, Model: i-Polish

Name: Cordless Prophy System, Model: i-Polish — FDA K211531
Creator: Guilin Woodpecker Medical Instrument Co., Ltd.
Keywords: Cordless Prophy System, Model: i-Polish, Cordless Prophy System, Model: i-Polish, K211531, EKX, FDA

United StatesEKXGuilin Woodpecker Medical Instrument Co., Ltd.

Verified

Official record identity

FDA application number: K211531
Decision date: December 17, 2021
Published decision: Substantially Equivalent

Classification

Product code: EKX

Published parties

Applicant: Guilin Woodpecker Medical Instrument Co., Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2021-05-17
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.4200

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.