Cleared Traditional

6.0 X 5.7MM DENTAL IMPLANT (K010185) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K010185 · Bicon, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
710d
Days
Class 2
Risk

K010185 is an FDA 510(k) clearance for the 6.0 X 5.7MM DENTAL IMPLANT. 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 December 30, 2002 after a review of 710 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.

View all Bicon, Inc. devices

Submission Details

510(k) Number K010185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2001
Decision Date December 30, 2002
Days to Decision 710 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
583d slower than avg
Panel avg: 127d · This submission: 710d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 1542
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K010185.
Promimic ZrP Surface Dental Implant
K252731 · Promimic AB · May 2026
Adin Long Dental Implant System
K252031 · Adin Dental Implant Systems , Ltd. · Mar 2026
ZENEX Implant System_Short (R-System)
K253334 · Izenimplant Co., Ltd. · Mar 2026
Straumann® BLC Implants - Indication Widening
K252168 · Institut Straumann AG · Mar 2026
Dentis SQ-SL AXEL Fixture
K253493 · Dentis Co., Ltd. · Mar 2026
Nobel Biocare S Series Implants
K252197 · Nobel Biocare AB · Feb 2026