Cleared Traditional

K150076 - Sonic Surgeon 310L

K150076 is an FDA 510(k) clearance for Sonic Surgeon 310L, manufactured by Dong IL Technology , Ltd.. The device is a Class 2 Dental device with product code DZI cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K150076 · Dong IL Technology , Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
139d
Days
Class 2
Risk

K150076 is an FDA 510(k) clearance for the Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L. Classified as Drill, Bone, Powered (product code DZI), Class II - Special Controls.

Submitted by Dong IL Technology , Ltd. (Hwaseong-Si, Gyeonggi-Do, KR). The FDA issued a Cleared decision on June 2, 2015 after a review of 139 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dong IL Technology , Ltd. devices

FDA 510(k) Submission Details - K150076

510(k) Number K150076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2015
Decision Date June 02, 2015
Days to Decision 139 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 127d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 33
Devices cleared under the same product code (DZI) and FDA review panel - the closest regulatory comparables to K150076.
Piezosurgery White
K171326 · Mectron S.P.A. · Apr 2018
PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE
K171958 · Mectron S.P.A. · Jan 2018
TRAUS SUS10
K151171 · Saeshin Precision Co., Ltd. · Sep 2015
PIEZOMED
K133488 · W&H Dentalwerk Buermoos GmbH · Oct 2014
PIEZOTOME 2
K091331 · Satelec · Dec 2009
IMPLANT CENTER 2
K091252 · Satelec · Jul 2009