Cleared Traditional

Dynamic TiBase

K232151 · Talladium Espa?a, SL · Dental

Oct 2023

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K232151 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 October 17, 2023, 90 days after receiving the submission on July 19, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K232151 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 19, 2023
Decision Date	October 17, 2023
Days to Decision	90 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.