Cleared Traditional

K130949 - CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS

K130949 is the FDA 510(k) clearance for CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS by Biomet 3i. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K130949 · Biomet 3i · Dental device
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Jul 2013
Decision
116d
Days
Class 2
Risk

K130949 is an FDA 510(k) clearance for the CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Biomet 3i (Palm Beach Gardens, US). The FDA issued a Cleared decision on July 30, 2013 after a review of 116 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. 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 Biomet 3i devices

Submission Details

510(k) Number K130949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2013
Decision Date July 30, 2013
Days to Decision 116 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 127d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 589
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K130949.
NOBELACTIVE WIDE PLATFORM (WP)
K133731 · Nobel Biocare AB · May 2014
ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED
K133339 · Zimmer Dental, Inc. · Mar 2014
ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM
K132258 · Zimmer Dental, Inc. · Nov 2013
INCLUSIVE TAPERED IMPLANT SYSTEM
K121406 · Prismatik Dentalcraft, Inc. · Feb 2013
TS IMPLANT SYSTEM
K121585 · Osstem Implant Co., Ltd. · Jan 2013
TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS
K122855 · Straumann USA · Dec 2012