Cleared Traditional

K180184 - Zeramex XT Dental Implant System

K180184 is the FDA 510(k) clearance for Zeramex XT Dental Implant System by Dentalpoint AG. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 297-day FDA review.

K180184 · Dentalpoint AG · Dental device
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Nov 2018
Decision
297d
Days
Class 2
Risk

K180184 is an FDA 510(k) clearance for the Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant 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 Dentalpoint AG (Spreitenbach, CH). The FDA issued a Cleared decision on November 16, 2018 after a review of 297 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 Dentalpoint AG devices

Submission Details

510(k) Number K180184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2018
Decision Date November 16, 2018
Days to Decision 297 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
170d slower than avg
Panel avg: 127d · This submission: 297d
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

Mapi USA, Inc.
Elizabeth Rose

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 463
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K180184.
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On1 Universal Abutment
K181869 · Nobel Biocare AB · Dec 2018
A.B. Dental Devices Dental Implants System
K181381 · A.B. Dental Device , Ltd. · Nov 2018
Universal Base Abutment
K180899 · Nobel Biocare AB · Oct 2018
Sirona Dental CAD/CAM System
K181520 · Dentsply Sirona · Oct 2018
Straumann SC Variobase Abutments
K173945 · Institut Straumann AG · Oct 2018