Cleared Abbreviated

PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY (K080220) - FDA 510(k) Clearance

Also marketed or referenced as:
ULTRASONIC DEBRIDMENT DEVICE

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K080220 · Italia Medica S.R.L. · Dental device
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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

Submission Details

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.

Device Classification

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.

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All 47
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