Cleared Special

K111216 - OSSEOTITE 2 DENTAL IMPLANTS

K111216 is an FDA 510(k) clearance for OSSEOTITE 2 DENTAL IMPLANTS, manufactured by Biomet 3i, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 200-day FDA review.

K111216 · Biomet 3i, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
200d
Days
Class 2
Risk

K111216 is an FDA 510(k) clearance for the OSSEOTITE 2 DENTAL IMPLANTS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Biomet 3i, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on November 18, 2011 after a review of 200 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. 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 - K111216

510(k) Number K111216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2011
Decision Date November 18, 2011
Days to Decision 200 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
72d slower than avg
Panel avg: 128d · This submission: 200d
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 1483
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K111216.
TAPERED SCREW-VENT X IMPLANT
K112160 · Zimmer Dental, Inc. · Dec 2011
ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT
K111889 · Zimmer Dental, Inc. · Dec 2011
ANYRIDGE INTERNAL IMPLANT SYSTEM
K110955 · Megagen Co., Ltd. · Nov 2011
DIOSLIMON IMPLANT SYSTEM
K112746 · Dio Corporation · Oct 2011
CSM SUBMERGED-R IMPLANT SYSTEM
K111120 · Csm Implant · Oct 2011
STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM
K111357 · Straumann USA · Oct 2011
K111216 · OSSEOTITE 2 DENTAL IMPLANTS
Download PDF FDA Summary Biomet 3i, Inc.