FDA · official record K192412Substantially Equivalent

SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece

Name: SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece — FDA K192412
Creator: Dentalez, Inc.
Keywords: SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece, SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece, K192412, EFB, FDA

United StatesEFBDentalez, Inc.

Verified

Official record identity

FDA application number: K192412
Decision date: January 06, 2020
Published decision: Substantially Equivalent

Classification

Product code: EFB

Published parties

Applicant: Dentalez, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2019-09-04
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.