Cleared Traditional

Multi-unit Abutments (K191123) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191123 · Medentika GmbH · Dental device
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Jan 2020
Decision
252d
Days
Class 2
Risk

K191123 is an FDA 510(k) clearance for the Multi-unit Abutments. 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 Medentika GmbH (Hugelsheim, DE). The FDA issued a Cleared decision on January 6, 2020 after a review of 252 days - an extended review cycle.

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. 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 Medentika GmbH devices

Submission Details

510(k) Number K191123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2019
Decision Date January 06, 2020
Days to Decision 252 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
125d slower than avg
Panel avg: 127d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Straumann USA, LLC
Jennifer M. Jackson

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NHA Abutment, Implant, Dental, Endosseous

All 318
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K191123.
Elos Accurate Customized Abutment
K191890 · Elos Medtech Pinol A/S · Feb 2020
TruAbutment DS
K183106 · Truabutment, Inc. · Jan 2020
Healing Abutments and Cover Screws
K192436 · Dentium Co., Ltd. · Jan 2020
Straumann Ceramic Healing Abutments
K192893 · Institut Straumann AG · Jan 2020
Elos Accurate Customized Abutment
K192457 · Elos Medtech Pinol A/S · Jan 2020
Neodent Implant System- GM Titanium Base for Bridge
K192229 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Dec 2019