Cleared Traditional

K080761 - BONART'S ARTEOTOMY OMI AND OPI ULTRASON...

K080761 is an FDA 510(k) clearance for BONART'S ARTEOTOMY OMI AND OPI ULTRASON..., 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 160-day FDA review.

K080761 · Bonart Co., Ltd. · Dental device
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Aug 2008
Decision
160d
Days
Class 2
Risk

K080761 is an FDA 510(k) clearance for the BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES. Classified as Drill, Bone, Powered (product code DZI), Class II - Special Controls.

Submitted by Bonart Co., Ltd. (Walnut, US). The FDA issued a Cleared decision on August 25, 2008 after a review of 160 days - an extended review cycle.

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 Bonart Co., Ltd. devices

FDA 510(k) Submission Details - K080761

510(k) Number K080761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2008
Decision Date August 25, 2008
Days to Decision 160 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
33d slower than avg
Panel avg: 127d · This submission: 160d
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 K080761.
IMPLANT CENTER 2
K091252 · Satelec · Jul 2009
SYNTHES 90 DEGREE SCREWDRIVER
K082649 · Synthes (Usa) · Apr 2009
STRAUMANN GUIDED INSTRUMENTS
K082532 · Straumann USA · Oct 2008
VARIOSURG
K073678 · Nakanishi, Inc. · Jul 2008
EMS PIEZON MASTER SURGERY
K072146 · E.M.S Electro Medical Systems S.A · Dec 2007
PIEZOTOME
K060274 · Satelec · May 2006