510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K080220Substantially Equivalent

Piezo Ultrasonic Device, Model Ultrasonic Bone Surgery; Ultrasonic Debridment Device

Italia Medica S.r.l., Ormond Beach FL / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K080220 is the FDA 510(k) clearance record for PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE, a class II device, cleared for Italia Medica S.R.L. on under FDA product code DZI (Drill, Bone, Powered). FDA records list one 510(k) clearance for Italia Medica S.R.L. As of , FDA records show no recalls naming K080220.

Clearance record

Decision date
Received
(181 days to decision)
Product code
DZI Drill, Bone, Powered
Regulation
21 CFR 872.4120
Device class
Class II
Review panel
Dental
Applicant
Italia Medica S.R.L. 110 E. Granada Blvd., Suite 207, Ormond Beach FL
510(k) summary
Statement
Third party review
No

Clearances, product code DZI

Trailing 12 months
3 clearances under product code DZI in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DZI, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20261
August 20260
September 20260
October 20260