Cleared Traditional

K150076 - Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K150076 · Dong IL Technology , Ltd. · Dental device
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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

Submission Details

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.

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
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