Cleared Special

K020645 - MODIFICATION TO THE MAESTRO SYSTEM

K020645 is an FDA 510(k) clearance for MODIFICATION TO THE MAESTRO SYSTEM, manufactured by BioHorizons Implant Systems, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 15-day FDA review.

K020645 · BioHorizons Implant Systems, Inc. · Dental device
Download Printable Device Report (PDF)
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Mar 2002
Decision
15d
Days
Class 2
Risk

K020645 is an FDA 510(k) clearance for the MODIFICATION TO THE MAESTRO SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by BioHorizons Implant Systems, Inc. (Birmingham, US). The FDA issued a Cleared decision on March 15, 2002 after a review of 15 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all BioHorizons Implant Systems, Inc. devices

FDA 510(k) Submission Details - K020645

510(k) Number K020645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2002
Decision Date March 15, 2002
Days to Decision 15 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 127d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

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 820
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K020645.
REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162
K020646 · Nobel Biocare Uas, Inc. · May 2002
OSSEOTITE NT DENTAL IMPLANTS & ACCESSORIES
K014235 · Implant Innovations, Inc. · May 2002
ACE HA SCREW DENTAL IMPLANT SYSTEM
K021244 · Ace Surgical Supply Co., Inc. · May 2002
ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM
K020096 · Institut Straumann AG · Feb 2002
SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT
K013891 · Institut Straumann AG · Feb 2002
MODIFICATION TO THE MAESTRO SYSTEM
K020133 · BioHorizons Implant Systems, Inc. · Jan 2002