Cleared Traditional

K032454 - SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM)

K032454 is an FDA 510(k) clearance for SILHOUETTE(TM) IC OR SILHOUETTE(TM) & L..., manufactured by Bio-Lok Intl., Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K032454 · Bio-Lok Intl., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
206d
Days
Class 2
Risk

K032454 is an FDA 510(k) clearance for the SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM). Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Bio-Lok Intl., Inc. (Stillwater, US). The FDA issued a Cleared decision on March 4, 2004 after a review of 206 days - an extended review 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: 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 Bio-Lok Intl., Inc. devices

FDA 510(k) Submission Details - K032454

510(k) Number K032454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2003
Decision Date March 04, 2004
Days to Decision 206 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 127d · This submission: 206d
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 1012
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K032454.
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3I PATIENT-SPECIFIC DENTAL ABUTMENT AND OVERDENTURE BAR
K032263 · Implant Innovations, Inc. · Jan 2004