Cleared Abbreviated

K083569 - SURGYBONE

K083569 is an FDA 510(k) clearance for SURGYBONE, manufactured by Silfradent S.R.L.. The device is a Class 2 Dental device with product code DZI cleared through the Abbreviated 510(k) pathway after a 119-day FDA review.

K083569 · Silfradent S.R.L. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
119d
Days
Class 2
Risk

K083569 is an FDA 510(k) clearance for the SURGYBONE. Classified as Drill, Bone, Powered (product code DZI), Class II - Special Controls.

Submitted by Silfradent S.R.L. (Ormond Beach, US). The FDA issued a Cleared decision on April 1, 2009 after a review of 119 days - within the typical 510(k) review window.

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 Silfradent S.R.L. devices

FDA 510(k) Submission Details - K083569

510(k) Number K083569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2008
Decision Date April 01, 2009
Days to Decision 119 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 127d · This submission: 119d
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 K083569.
PIEZOTOME 2
K091331 · Satelec · Dec 2009
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