Cleared Abbreviated

SURGYBONE (K083569) - FDA 510(k) Clearance

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

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

Submission Details

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.

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.

Regulatory Peers - DZI Drill, Bone, Powered

All 47
Devices cleared under the same product code (DZI) and FDA review panel - the closest regulatory comparables to K083569.
VarioSurg 4
K254163 · Nakanishi, Inc. · Dec 2025
MT-Bone
K242432 · Mectron S.P.A. · Aug 2024
Surgical Drive System (Model: ES70, ES90, E8)
K240340 · Guangdong Jinme Medical Technology Co., Ltd. · Jul 2024
Guided Surgery Kit
K231087 · Implant Direct Sybron Manufacturing, LLC · Aug 2023
TRAUS SUS20
K192561 · Saeshin Precision Co., Ltd. · Jul 2020
Surgical Drills
K200265 · Implant Direct Sybron Manufacturing, LLC · Jun 2020