Cleared Abbreviated

K101545 - GENESIS IMPLANT SYSTEM

K101545 is an FDA 510(k) clearance for GENESIS IMPLANT SYSTEM, manufactured by Keystone Dental. The device is a Class 2 Dental device with product code DZE cleared through the Abbreviated 510(k) pathway after a 147-day FDA review.

K101545 · Keystone Dental · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
147d
Days
Class 2
Risk

K101545 is an FDA 510(k) clearance for the GENESIS IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Keystone Dental (Burlington, US). The FDA issued a Cleared decision on October 28, 2010 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K101545

510(k) Number K101545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2010
Decision Date October 28, 2010
Days to Decision 147 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 128d · This submission: 147d
Pathway characteristics
Standards-based clearance path.

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 1483
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K101545.
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ENDOSSEOUS DENTAL IMPLANT
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K101096 · Hiossen, Inc. · Oct 2010
BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT
K101849 · Bicon, LLC · Oct 2010
K101545 · GENESIS IMPLANT SYSTEM
Download PDF FDA Summary Keystone Dental