FDA · official record K070811Substantially Equivalent

CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000

Name: CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000 — FDA K070811
Creator: Dexco
Keywords: CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000, CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000, K070811, MUH, FDA

United StatesMUHDexco

Verified

Official record identity

FDA application number: K070811
Decision date: July 05, 2007
Published decision: Substantially Equivalent

Classification

Product code: MUH

Published parties

Applicant: Dexco

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2007-03-26
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.1800

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.