Cleared Traditional

Dynamic TiBase

K212108 · Talladium Espa?a, SL · Dental

Sep 2021

Decision

80d

Days

Class 2

Risk

About This 510(k) Submission

K212108 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 September 24, 2021, 80 days after receiving the submission on July 6, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K212108 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 06, 2021
Decision Date	September 24, 2021
Days to Decision	80 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.