Cleared Traditional

K062636 - OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP, MICROMINIPLANT, DENTAL IMPLANTS

K062636 is an FDA 510(k) clearance for OSSEOTITE, manufactured by Implant Innovations, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K062636 · Implant Innovations, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
269d
Days
Class 2
Risk

K062636 is an FDA 510(k) clearance for the OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP, M.... Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Implant Innovations, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on June 1, 2007 after a review of 269 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.

View all Implant Innovations, Inc. devices

FDA 510(k) Submission Details - K062636

510(k) Number K062636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2006
Decision Date June 01, 2007
Days to Decision 269 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
142d slower than avg
Panel avg: 127d · This submission: 269d
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 1185
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K062636.
GS SYSTEM
K063861 · Osstem Implant Co., Ltd. · Sep 2007
ZIMMER PATIENT-SPECIFIC ABUTMENT, INTERNAL HEX, TITANIUM
K071439 · Zimmer Dental, Inc. · Sep 2007
NOBELACTIVE INTERNAL CONNECTION IMPLANT
K071370 · Nobel Biocare AB · Aug 2007
ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13
K071235 · Zimmer Dental, Inc. · May 2007
3I OSSEOTITE CERTAIN DENTAL IMPLANTS
K063341 · Implant Innovations, Inc. · Apr 2007
OSSEOSPEED 4.0S-6MM, MODEL 24619
K063779 · Astra Tech, Inc. · Apr 2007