Cleared Traditional

K152125 - Oral Surgery System and Accessories (FDA 510(k) Clearance)

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

K152125 · Bonart Co., Ltd. · Dental device
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Aug 2016
Decision
381d
Days
Class 2
Risk

K152125 is an FDA 510(k) clearance for the Oral Surgery System and Accessories. Classified as Drill, Bone, Powered (product code DZI), Class II - Special Controls.

Submitted by Bonart Co., Ltd. (Xinzhuang Dist., TW). The FDA issued a Cleared decision on August 15, 2016 after a review of 381 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Bonart Co., Ltd. devices

Submission Details

510(k) Number K152125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2015
Decision Date August 15, 2016
Days to Decision 381 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
254d slower than avg
Panel avg: 127d · This submission: 381d
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
Devices cleared under the same product code (DZI) and FDA review panel - the closest regulatory comparables to K152125.
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