Cleared Traditional

K120043 - CSM INTERNAL-R IMPLANT SYSTEM

K120043 is the FDA 510(k) clearance for CSM INTERNAL-R IMPLANT SYSTEM by Csm Implant. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K120043 · Csm Implant · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
113d
Days
Class 2
Risk

K120043 is an FDA 510(k) clearance for the CSM INTERNAL-R IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Csm Implant (Brea, US). The FDA issued a Cleared decision on April 27, 2012 after a review of 113 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 Csm Implant devices

Submission Details

510(k) Number K120043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2012
Decision Date April 27, 2012
Days to Decision 113 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
14d faster than avg
Panel avg: 127d · This submission: 113d
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 K120043.
ZIMMER DENTAL TAPERED SCREW-VENT X
K113753 · Zimmer Dental, Inc. · Aug 2012
ET/SS IMPLANT SYSTEM
K120847 · Osstem Implant Co., Ltd. · Aug 2012
BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM
K121131 · Straumann USA · Jun 2012
HAPTITE COATING IMPLANT SYSTEM
K111364 · Dentis Co., Ltd. · Feb 2012
TAPERED SCREW-VENT X IMPLANT
K112160 · Zimmer Dental, Inc. · Dec 2011
ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT
K111889 · Zimmer Dental, Inc. · Dec 2011