Cleared Traditional

K150076 - Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L

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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 128d · 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 Consultant

Plusglobal
PETER CHUNG

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DZI Drill, Bone, Powered

All 49
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