Cleared Traditional

Dynamic TiBase

K243530 · Talladium Espa?a, SL · Dental

May 2025

Decision

197d

Days

Class 2

Risk

About This 510(k) Submission

K243530 is an FDA 510(k) clearance for the Dynamic TiBase, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Talladium Espa?a, SL (Lleida, ES). The FDA issued a Cleared decision on May 30, 2025, 197 days after receiving the submission on November 14, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K243530 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 14, 2024
Decision Date	May 30, 2025
Days to Decision	197 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.