Cleared Traditional

K151608 - 4plus6Line Abutment System

K151608 is an FDA 510(k) clearance for 4plus6Line Abutment System, manufactured by Ot Medical GmbH. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 303-day FDA review.

K151608 · Ot Medical GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
303d
Days
Class 2
Risk

K151608 is an FDA 510(k) clearance for the 4plus6Line Abutment System. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Ot Medical GmbH (Bremen, DE). The FDA issued a Cleared decision on April 13, 2016 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - 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 - K151608

510(k) Number K151608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2015
Decision Date April 13, 2016
Days to Decision 303 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
176d slower than avg
Panel avg: 127d · This submission: 303d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NHA Device Classification - Class 2, Special Controls

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
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 - NHA Abutment, Implant, Dental, Endosseous

All 559
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K151608.
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K151439 · Dentsply International, Inc. · Feb 2016