Cleared Traditional

Multi-Unit DAS System

K243732 · Talladium Espa?a, SL · Dental

Jan 2026

Decision

421d

Days

Class 2

Risk

About This 510(k) Submission

K243732 is an FDA 510(k) clearance for the Multi-Unit DAS System, 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 January 29, 2026, 421 days after receiving the submission on December 4, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K243732 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 04, 2024
Decision Date	January 29, 2026
Days to Decision	421 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.