Cleared Traditional

K031568 - BICONITE SURFACE TREATMENT

K031568 is an FDA 510(k) clearance for BICONITE SURFACE TREATMENT, manufactured by Bicon, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 553-day FDA review.

K031568 · Bicon, Inc. · Dental device
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Nov 2004
Decision
553d
Days
Class 2
Risk

K031568 is an FDA 510(k) clearance for the BICONITE SURFACE TREATMENT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Bicon, Inc. (Boston, US). The FDA issued a Cleared decision on November 23, 2004 after a review of 553 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

FDA 510(k) Submission Details - K031568

510(k) Number K031568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2003
Decision Date November 23, 2004
Days to Decision 553 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
425d slower than avg
Panel avg: 128d · This submission: 553d
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 1500
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K031568.
TITAN DENTAL IMPLANT SYSTEM
K042971 · Titan Implants, Inc. · Jan 2005
LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS)
K042345 · Mondeal Medical Systems GmbH · Jan 2005
ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320
K043226 · Imtec Corp. · Jan 2005
THE 5.0 X 6.0MM DENTAL IMPLANT
K042637 · Bicon, Inc. · Nov 2004
NEOPLANT IMPLANT SYSTEM
K042339 · Neobiotech Co., Ltd. · Nov 2004
STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM
K041271 · Sterngold · Oct 2004
K031568 · BICONITE SURFACE TREATMENT
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