Cleared Traditional

K151439 - ATLANTIS ISUS

K151439 is the FDA 510(k) clearance for ATLANTIS ISUS by Dentsply International, Inc.. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K151439 · Dentsply International, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
266d
Days
Class 2
Risk

K151439 is an FDA 510(k) clearance for the ATLANTIS ISUS. 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 International, Inc. (York, US). The FDA issued a Cleared decision on February 19, 2016 after a review of 266 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 International, Inc. devices

Submission Details

510(k) Number K151439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2015
Decision Date February 19, 2016
Days to Decision 266 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
139d slower than avg
Panel avg: 127d · This submission: 266d
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 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 K151439.
ATLANTIS Abutment for CONELOG implant
K161030 · Dentsply Sirona · Aug 2016
NobelProcera HT ML FCZ Implant Bridge and Framework
K160158 · Nobel Biocare AB · Jul 2016
NobelDesign Software
K153036 · Nobel Biocare AB · Jun 2016
ATLANTIS Abutment for NobelActive 3.0
K151039 · Dentsply International, Inc. · Jan 2016
BioHorizons CAD/CAM Abutments
K151621 · BioHorizons Implant Systems, Inc. · Jan 2016
Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System
K151798 · Prismatik Dentalcraft, Inc. · Nov 2015