Cleared Traditional

Dentsply Sirona Titanium Bases system

K250295 · Dentsply Sirona · Dental

Apr 2025

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K250295 is an FDA 510(k) clearance for the Dentsply Sirona Titanium Bases system, 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 April 30, 2025, 89 days after receiving the submission on January 31, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K250295 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 31, 2025
Decision Date	April 30, 2025
Days to Decision	89 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.