Cleared Traditional

K113113 - ENDOSSEOUS DENTAL IMPLANT

K113113 is an FDA 510(k) clearance for ENDOSSEOUS DENTAL IMPLANT, manufactured by Ot Medical GmbH. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 393-day FDA review.

K113113 · Ot Medical GmbH · Dental device
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Nov 2012
Decision
393d
Days
Class 2
Risk

K113113 is an FDA 510(k) clearance for the ENDOSSEOUS DENTAL IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Ot Medical GmbH (Bremen, DE). The FDA issued a Cleared decision on November 16, 2012 after a review of 393 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Ot Medical GmbH devices

FDA 510(k) Submission Details - K113113

510(k) Number K113113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2011
Decision Date November 16, 2012
Days to Decision 393 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
266d slower than avg
Panel avg: 127d · This submission: 393d
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 832
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