Cleared Special

K131748 - OSSEOFUSE DENTAL IMPLANT SYSTEM

K131748 is an FDA 510(k) clearance for OSSEOFUSE DENTAL IMPLANT SYSTEM, manufactured by Osseofuse, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 139-day FDA review.

K131748 · Osseofuse, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
139d
Days
Class 2
Risk

K131748 is an FDA 510(k) clearance for the OSSEOFUSE DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Osseofuse, Inc. (Brea, US). The FDA issued a Cleared decision on October 31, 2013 after a review of 139 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K131748

510(k) Number K131748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2013
Decision Date October 31, 2013
Days to Decision 139 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
11d slower than avg
Panel avg: 128d · This submission: 139d
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 1523
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K131748.
IQ IMPLANTS
K130829 · Iq Implants , Ltd. · Nov 2013
ANKER DENTAL IMPLANT SYSTEM
K131165 · Alliance Global · Nov 2013
LUNA DENTAL IMPLANT SYSTEM
K123155 · Shinhung Mst Co., Ltd. · Oct 2013
OSSEOSPEED PROFILE EV
K130999 · Dentsply Implants Manufacturing GmbH · Oct 2013
Z5MLB, Z5MLC
K131701 · Z-Systems AG · Sep 2013
PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT
K130462 · Paltop Advanced Dental Solutions, Ltd. · Aug 2013
K131748 · OSSEOFUSE DENTAL IMPLANT SYSTEM
Download PDF FDA Summary Osseofuse, Inc.