Cleared Traditional

K101849 - BICON DENTAL IMPLANT SYSTEM 3.0MM BICON...

K101849 is an FDA 510(k) clearance for BICON DENTAL IMPLANT SYSTEM 3.0MM BICON..., manufactured by Bicon, LLC. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K101849 · Bicon, LLC · Dental device
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Oct 2010
Decision
92d
Days
Class 2
Risk

K101849 is an FDA 510(k) clearance for the BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Bicon, LLC (Boston, US). The FDA issued a Cleared decision on October 1, 2010 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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 Bicon, LLC devices

FDA 510(k) Submission Details - K101849

510(k) Number K101849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2010
Decision Date October 01, 2010
Days to Decision 92 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
35d faster than avg
Panel avg: 127d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 - DZE Implant, Endosseous, Root-form

All 838
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K101849.
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K101977 · Zimmer Dental, Inc. · Sep 2010
MODIFICATION TO: HG III ULTRA WIDE SYSTEM
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