Cleared Abbreviated

K080220 - PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY

Also marketed or referenced as:
ULTRASONIC DEBRIDMENT DEVICE

K080220 is an FDA 510(k) clearance for PIEZO ULTRASONIC DEVICE, manufactured by Italia Medica S.R.L.. The device is a Class 2 Dental device with product code DZI cleared through the Abbreviated 510(k) pathway after a 181-day FDA review.

K080220 · Italia Medica S.R.L. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
181d
Days
Class 2
Risk

K080220 is an FDA 510(k) clearance for the PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY. Classified as Drill, Bone, Powered (product code DZI), Class II - Special Controls.

Submitted by Italia Medica S.R.L. (Ormond Beach, US). The FDA issued a Cleared decision on July 28, 2008 after a review of 181 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4120 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Italia Medica S.R.L. devices

FDA 510(k) Submission Details - K080220

510(k) Number K080220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2008
Decision Date July 28, 2008
Days to Decision 181 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 127d · This submission: 181d
Pathway characteristics
Standards-based clearance path.

DZI Device Classification - Class 2, Special Controls

Product Code DZI Drill, Bone, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZI Drill, Bone, Powered

All 34
Devices cleared under the same product code (DZI) and FDA review panel - the closest regulatory comparables to K080220.
IMPLANT CENTER 2
K091252 · Satelec · Jul 2009
SYNTHES 90 DEGREE SCREWDRIVER
K082649 · Synthes (Usa) · Apr 2009
STRAUMANN GUIDED INSTRUMENTS
K082532 · Straumann USA · Oct 2008
VARIOSURG
K073678 · Nakanishi, Inc. · Jul 2008
EMS PIEZON MASTER SURGERY
K072146 · E.M.S Electro Medical Systems S.A · Dec 2007
PIEZOTOME
K060274 · Satelec · May 2006