Cleared Traditional

K160626 - ATLANTIS Abutment for HIOSSEN ET implant

K160626 is an FDA 510(k) clearance for ATLANTIS Abutment for HIOSSEN ET implant, manufactured by Dentsply Sirona. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K160626 · Dentsply Sirona · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
175d
Days
Class 2
Risk

K160626 is an FDA 510(k) clearance for the ATLANTIS Abutment for HIOSSEN ET implant. 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 Dentsply Sirona (York, US). The FDA issued a Cleared decision on August 29, 2016 after a review of 175 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 Dentsply Sirona devices

FDA 510(k) Submission Details - K160626

510(k) Number K160626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2016
Decision Date August 29, 2016
Days to Decision 175 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
48d slower than avg
Panel avg: 127d · This submission: 175d
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 566
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K160626.
ATLANTIS ISUS Implant Suprastructures
K160207 · Dentsply International, Inc. · Sep 2016
Neodent Implant System - Titanium Base for CEREC
K160964 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Sep 2016
Dentium Implantium & SuperLine Prosthetics
K160828 · Dentium Co., Ltd. · Sep 2016
GPS Angled Abutment
K153509 · Implant Direct Sybron Manufacturing, LLC · Aug 2016
ATLANTIS Abutment for CONELOG implant
K161030 · Dentsply Sirona · Aug 2016
Burn-out Cylinder and Angled Screw Abutments
K160483 · Dentium Co., Ltd. · Aug 2016