Cleared Traditional

Straumann SC Variobase Abutments (K173945) - FDA 510(k) Clearance

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

K173945 · Institut Straumann AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2018
Decision
283d
Days
Class 2
Risk

K173945 is an FDA 510(k) clearance for the Straumann SC Variobase 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 Institut Straumann AG (Basel, CH). The FDA issued a Cleared decision on October 5, 2018 after a review of 283 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 Institut Straumann AG devices

Submission Details

510(k) Number K173945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2017
Decision Date October 05, 2018
Days to Decision 283 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
156d slower than avg
Panel avg: 127d · This submission: 283d
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 K173945.
Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System
K180184 · Dentalpoint AG · Nov 2018
Universal Base Abutment
K180899 · Nobel Biocare AB · Oct 2018
Sirona Dental CAD/CAM System
K181520 · Dentsply Sirona · Oct 2018
BioHorizons CAD/CAM Bars
K180998 · BioHorizons Implant Systems, Inc. · Sep 2018
TruBase S
K171532 · Truabutment, Inc. · Sep 2018
InterActive SMARTBase Abutments
K181359 · Implant Direct Sybron Manufacturing, LLC · Aug 2018