Cleared Special

K041938 - MAXIMUS OS (OVERDENTURE SYSTEM)

K041938 is the FDA 510(k) clearance for MAXIMUS OS (OVERDENTURE SYSTEM) by BioHorizons Implant Systems, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Special 510(k) pathway after a 3-day FDA review.

K041938 · BioHorizons Implant Systems, Inc. · Dental device
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Jul 2004
Decision
3d
Days
Class 2
Risk

K041938 is an FDA 510(k) clearance for the MAXIMUS OS (OVERDENTURE 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 July 22, 2004 after a review of 3 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

Submission Details

510(k) Number K041938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2004
Decision Date July 22, 2004
Days to Decision 3 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
124d faster than avg
Panel avg: 127d · This submission: 3d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 582
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K041938.
THE GUIDED SURGERY CONCEPT
K050393 · Nobel Biocare AB · May 2005
GROOVY IMPLANTS
K050258 · Nobel Biocare AB · Apr 2005
THE PRODIGY SYSTEM DENTAL IMPLANTS
K042429 · BioHorizons Implant Systems, Inc. · Sep 2004
STRAUMANN DENTAL IMPLANT SYSTEM
K033984 · Institut Straumann AG · Jun 2004
MODIFICATION TO OSSEOTITE NT CERTAIN IMPLANTS
K041402 · Implant Innovations, Inc. · Jun 2004
KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES)
K040891 · KLS-Martin L.P. · May 2004