Cleared Traditional

K111120 - CSM SUBMERGED-R IMPLANT SYSTEM

K111120 is the FDA 510(k) clearance for CSM SUBMERGED-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 176-day FDA review.

K111120 · Csm Implant · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
176d
Days
Class 2
Risk

K111120 is an FDA 510(k) clearance for the CSM SUBMERGED-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 October 14, 2011 after a review of 176 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 Csm Implant devices

Submission Details

510(k) Number K111120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2011
Decision Date October 14, 2011
Days to Decision 176 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
49d slower than avg
Panel avg: 127d · This submission: 176d
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 K111120.
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STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM
K111357 · Straumann USA · Oct 2011
INCLUSIVE MINI IMPLANT
K100932 · Prismatik Dentalcraft, Inc. · Dec 2010
NOBEL ACTIVE 3.0
K102436 · Nobel Biocare AB · Dec 2010