Cleared Traditional

ATLANTIS ISUS

K151439 · Dentsply International, Inc. · Dental

Feb 2016

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K151439 is an FDA 510(k) clearance for the ATLANTIS ISUS, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Dentsply International, Inc. (York, US). The FDA issued a Cleared decision on February 19, 2016, 266 days after receiving the submission on May 29, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K151439 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	NHA — Abutment, Implant, Dental, Endosseous
Device Class	Class II — 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.