Cleared Traditional

Atlantis? Abutments in Titanium

K252343 · Dentsply Sirona · Dental

Dec 2025

Decision

134d

Days

Class 2

Risk

About This 510(k) Submission

K252343 is an FDA 510(k) clearance for the Atlantis? Abutments in Titanium, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Dentsply Sirona (York, US). The FDA issued a Cleared decision on December 9, 2025, 134 days after receiving the submission on July 28, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K252343 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 28, 2025
Decision Date	December 09, 2025
Days to Decision	134 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.