Cleared Traditional

Atlantis suprastructures

K193064 · Dentsply Sirona, Inc. · Dental

Mar 2020

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K193064 is an FDA 510(k) clearance for the Atlantis suprastructures, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Dentsply Sirona, Inc. (York, US). The FDA issued a Cleared decision on March 3, 2020, 120 days after receiving the submission on November 4, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K193064 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 04, 2019
Decision Date	March 03, 2020
Days to Decision	120 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.