Cleared Traditional

Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases (K180564) - FDA 510(k) Clearance

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

K180564 · Medentika GmbH · Dental device
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Jan 2019
Decision
308d
Days
Class 2
Risk

K180564 is an FDA 510(k) clearance for the Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiB.... 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 (Huegelsheim, DE). The FDA issued a Cleared decision on January 7, 2019 after a review of 308 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 Medentika GmbH devices

Submission Details

510(k) Number K180564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2018
Decision Date January 07, 2019
Days to Decision 308 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
181d slower than avg
Panel avg: 127d · This submission: 308d
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 K180564.
Preat Abutments
K183518 · Preat Corporation · Mar 2019
Cortex CAD/CAM Abutments
K181580 · Cortex Dental Implants Industries , Ltd. · Jan 2019
MIS LOCKiT Abutments System, OT-Equators and Ball Attachments
K182228 · Mis Implants Technologies , Ltd. · Jan 2019
DIO CAD/CAM Abutment
K181037 · Dio Corporation · Dec 2018
On1 Universal Abutment
K181869 · Nobel Biocare AB · Dec 2018
A.B. Dental Devices Dental Implants System
K181381 · A.B. Dental Device , Ltd. · Nov 2018