Cleared Traditional

K100785 - BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES (FDA 510(k) Clearance)

Class I Dental device.

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.

View all Bonart Co., Ltd. devices

Submission Details

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
132d slower than avg
Panel avg: 127d · This submission: 259d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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
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