Cleared Traditional

K111120 - CSM SUBMERGED-R IMPLANT SYSTEM

K111120 is an FDA 510(k) clearance for CSM SUBMERGED-R IMPLANT SYSTEM, manufactured by Csm Implant. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K111120 · Csm Implant · Dental device
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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

FDA 510(k) Submission Details - K111120

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
Combination Product No
PCCP Authorized No
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.

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 1187
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K111120.
ANYRIDGE INTERNAL IMPLANT SYSTEM
K110955 · Megagen Co., Ltd. · Nov 2011
OSSEOTITE 2 DENTAL IMPLANTS
K111216 · Biomet 3i, Inc. · Nov 2011
DIOSLIMON IMPLANT SYSTEM
K112746 · Dio Corporation · Oct 2011
STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM
K111357 · Straumann USA · Oct 2011
ASTRA TECH IMPLANT SYSTEM
K111287 · Astra Tech AB · Sep 2011
BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL
K111003 · Biodenta Swiss AG · Sep 2011