Cleared Traditional

K152125 - Oral Surgery System and Accessories

K152125 is an FDA 510(k) clearance for Oral Surgery System and Accessories, manufactured by Bonart Co., Ltd.. The device is a Class 2 Dental device with product code DZI cleared through the Traditional 510(k) pathway after a 381-day FDA review.

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

FDA 510(k) Submission Details - K152125

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.

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 31
Devices cleared under the same product code (DZI) and FDA review panel - the closest regulatory comparables to K152125.
PIEZOTOME CUBE
K172137 · Satelec - Acteon Group · May 2018
Piezosurgery White
K171326 · Mectron S.P.A. · Apr 2018
PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE
K171958 · Mectron S.P.A. · Jan 2018
PIEZOTOME 2
K091331 · Satelec · Dec 2009
IMPLANT CENTER 2
K091252 · Satelec · Jul 2009
SYNTHES 90 DEGREE SCREWDRIVER
K082649 · Synthes (Usa) · Apr 2009