Cleared Traditional

K972417 - THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEM

K972417 is an FDA 510(k) clearance for THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEM, 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 82-day FDA review.

K972417 · Bicon, Inc. · Dental device
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Sep 1997
Decision
82d
Days
Class 2
Risk

K972417 is an FDA 510(k) clearance for the THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEM. 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 September 17, 1997 after a review of 82 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bicon, Inc. devices

FDA 510(k) Submission Details - K972417

510(k) Number K972417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1997
Decision Date September 17, 1997
Days to Decision 82 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
45d faster than avg
Panel avg: 127d · This submission: 82d
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 940
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