Cleared Traditional

K100785 - BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES

K100785 is an FDA 510(k) clearance for BONART MODEL ART-IM1 IMPLANTOR SYSTEM &..., manufactured by Bonart Co., Ltd.. The device is a Class 1 Dental device with product code EBW cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K100785 · Bonart Co., Ltd. · Dental device
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Dec 2010
Decision
259d
Days
Class 1
Risk

K100785 is an FDA 510(k) clearance for the BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES. Classified as Controller, Foot, Handpiece And Cord (product code EBW), Class I - General Controls.

Submitted by Bonart Co., Ltd. (Walnut, US). The FDA issued a Cleared decision on December 3, 2010 after a review of 259 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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 - K100785

510(k) Number K100785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2010
Decision Date December 03, 2010
Days to Decision 259 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
131d slower than avg
Panel avg: 128d · This submission: 259d
Pathway characteristics
Predicate-based equivalence.

EBW Device Classification - Class 1, General Controls

Product Code EBW Controller, Foot, Handpiece And Cord
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EBW Controller, Foot, Handpiece And Cord

All 60
Devices cleared under the same product code (EBW) and FDA review panel - the closest regulatory comparables to K100785.
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