Cleared Traditional

K130999 - OSSEOSPEED PROFILE EV

K130999 is an FDA 510(k) clearance for OSSEOSPEED PROFILE EV, manufactured by Dentsply Implants Manufacturing GmbH. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K130999 · Dentsply Implants Manufacturing GmbH · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
198d
Days
Class 2
Risk

K130999 is an FDA 510(k) clearance for the OSSEOSPEED PROFILE EV. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Dentsply Implants Manufacturing GmbH (San Diego, US). The FDA issued a Cleared decision on October 25, 2013 after a review of 198 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.

FDA 510(k) Submission Details - K130999

510(k) Number K130999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2013
Decision Date October 25, 2013
Days to Decision 198 days
Submission Type Traditional
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
70d slower than avg
Panel avg: 128d · This submission: 198d
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 1523
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K130999.
ANKER DENTAL IMPLANT SYSTEM
K131165 · Alliance Global · Nov 2013
LUNA DENTAL IMPLANT SYSTEM
K123155 · Shinhung Mst Co., Ltd. · Oct 2013
OSSEOFUSE DENTAL IMPLANT SYSTEM
K131748 · Osseofuse, Inc. · Oct 2013
Z5MLB, Z5MLC
K131701 · Z-Systems AG · Sep 2013
PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT
K130462 · Paltop Advanced Dental Solutions, Ltd. · Aug 2013
LEGACY3 6MM LENGTH IMPLANTS
K131097 · Implant Direct Sybron Manufacturing, LLC · Aug 2013
K130999 · OSSEOSPEED PROFILE EV
Download PDF FDA Summary Dentsply Implants Man…