Dynamic TiBase; TRI Screws

FDA 510(k) K241170 · Talladium España, SL

Substantially Equivalent

510(k) numberK241170

Submission

Device name
Dynamic TiBase; TRI Screws
Applicant
Talladium España, SL
Lleida, ES
Received
April 26, 2024
Decision date
October 21, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NHA – Abutment, Implant, Dental, Endosseous
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3630
Specialty
Dental
Implant
Yes

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

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K261147Neodent Implant System - NeoConvert FitNHA · Traditional JJGC Indústria e Comércio de Materiais Dentários…07/01/2026SE
K261122Mist IcNHA · Traditional Imagine Milling Technologies, LLC06/27/2026SE
K260061BioHorizons CEREC Compatible Ti-BasesNHA · Traditional BioHorizons Implant Systems, Inc.06/26/2026SE
K253922Neodent Scannable Healing AbutmentNHA · Traditional JJGC Indústria e Comércio de Materiais Dentários…06/15/2026SE
K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)NHA · Abbreviated Smart Denture Conversions, LLC06/11/2026SE
K260564DESS Dental Smart SolutionsNHA · Traditional Terrats Medical SL06/09/2026SE
K252904SIC Abutments including CAD/CAM SolutionsNHA · Traditional Sic Invent AG06/03/2026SE
K253774Elos Accurate® Denture Fixation SystemNHA · Traditional Elos Medtech Pinol A/S05/20/2026SE
K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsNHA · Traditional Hiossen, Inc.05/14/2026SE

More from Hiossen, Inc.

510(k)DeviceDecision
K243732Multi-Unit DAS SystemNHA · Traditional 01/29/2026SE
K243425Guided DAS Surgical KitKCT · Traditional 07/22/2025SE
K243530Dynamic TiBaseNHA · Traditional 05/30/2025SE
K231559Multi-Unit DAS SystemNHA · Traditional 11/17/2023SE
K232151Dynamic TiBaseNHA · Traditional 10/17/2023SE
K212108Dynamic TiBaseNHA · Traditional 09/24/2021SE

Questions and answers

When was Dynamic TiBase; TRI Screws cleared by the FDA?

Dynamic TiBase; TRI Screws (K241170) received a 510(k) decision of Substantially Equivalent on October 21, 2024, 178 days after the submission was received.

What is the product code of K241170?

The FDA product code is NHA – Abutment, Implant, Dental, Endosseous, a Class II (moderate risk) device regulated under 21 CFR 872.3630.