Cleared Traditional

K130949 - CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS

K130949 is an FDA 510(k) clearance for CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS, manufactured by Biomet 3i. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K130949

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
Combination Product No
PCCP Authorized No
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.

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 1184
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K130949.
ANYONETM INTERNAL IMPLANT SYSTEM
K123988 · Megagen Implant Co., Ltd. · Aug 2013
TIARRAY DENTAL IMPLANT SYSTEM
K131345 · Nasseo, Inc. · Aug 2013
INTRA-LOCK OP DENTAL IMPLANT
K130140 · Intra-Lock International · Aug 2013
ETII SA FIXTURE SYSTEM
K123471 · Hiossen, Inc. · Jul 2013
QUANTUM DENTAL IMPLANT SYSTEM
K130787 · Quantum Bioengineering, Ltd. · Jun 2013
DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM
K122519 · Dio Corporation · May 2013