Cleared Traditional

Multi-Unit DAS System

K231559 · Talladium Espa?a, SL · Dental

Nov 2023

Decision

171d

Days

Class 2

Risk

About This 510(k) Submission

K231559 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 November 17, 2023, 171 days after receiving the submission on May 30, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K231559 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 30, 2023
Decision Date	November 17, 2023
Days to Decision	171 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.