Cleared Traditional

K041136 - MODIFICATION TO SILHOUETTE IC OR SILHOUETTE

Also marketed or referenced as:
LASER-LOK SURFACE TREATMENT -OPTIONAL SURFACE MODIFICATION TO IMPLANTS

K041136 is an FDA 510(k) clearance for MODIFICATION TO SILHOUETTE IC OR SILHOUETTE, 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 175-day FDA review.

K041136 · Bio-Lok Intl., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
175d
Days
Class 2
Risk

K041136 is an FDA 510(k) clearance for the MODIFICATION TO SILHOUETTE IC OR SILHOUETTE. 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 October 22, 2004 after a review of 175 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 - K041136

510(k) Number K041136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2004
Decision Date October 22, 2004
Days to Decision 175 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
48d slower than avg
Panel avg: 127d · This submission: 175d
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 K041136.
ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320
K043226 · Imtec Corp. · Jan 2005
NEOPLANT IMPLANT SYSTEM
K042339 · Neobiotech Co., Ltd. · Nov 2004
FRIADENT PLUS DENTAL IMPLANT SYSTEMS
K040170 · Friadent GmbH · Oct 2004
THE PRODIGY SYSTEM DENTAL IMPLANTS
K042429 · BioHorizons Implant Systems, Inc. · Sep 2004
MDI ORTHO
K042289 · Imtec Corp. · Sep 2004
ANKYLOS DENTAL IMPLANT SYSTEM
K041509 · Friadent GmbH · Aug 2004