Cleared Traditional

Atlantis? Abutments in Titanium for Straumann BLX and Neodent GM Implants

K251205 · Dentsply Sirona · Dental

Nov 2025

Decision

217d

Days

Class 2

Risk

About This 510(k) Submission

K251205 is an FDA 510(k) clearance for the Atlantis? Abutments in Titanium for Straumann BLX and Neodent GM Implants, 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 November 21, 2025, 217 days after receiving the submission on April 18, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K251205 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 18, 2025
Decision Date	November 21, 2025
Days to Decision	217 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.