FDA · official record K080220Substantially Equivalent

PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE

Name: PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE — FDA K080220
Creator: Italia Medica S.R.L.
Keywords: PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE, PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE, K080220, DZI, FDA

United StatesDZIItalia Medica S.R.L.

Verified

Official record identity

FDA application number: K080220
Decision date: July 28, 2008
Published decision: Substantially Equivalent

Classification

Product code: DZI

Published parties

Applicant: Italia Medica S.R.L.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Abbreviated
Received date: 2008-01-29
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.4120

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.