FDA · official record K012946Substantially Equivalent

SUNLITELED MODEL #2810

Name: SUNLITELED MODEL #2810 — FDA K012946
Creator: Kinetic Instruments, Inc.
Keywords: SUNLITELED MODEL #2810, SUNLITELED MODEL #2810, K012946, EBZ, FDA

United StatesEBZKinetic Instruments, Inc.

Verified

Official record identity

FDA application number: K012946
Decision date: October 02, 2001
Published decision: Substantially Equivalent

Classification

Product code: EBZ

Published parties

Applicant: Kinetic Instruments, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2001-09-04
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.6070

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.