Dynamic TiBase

FDA 510(k) K232151 · Talladium España, SL

Substantially Equivalent

510(k) numberK232151

Submission

Device name
Dynamic TiBase
Applicant
Talladium España, SL
Lleida, ES
Received
July 19, 2023
Decision date
October 17, 2023
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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K261122Mist IcNHA · Traditional Imagine Milling Technologies, LLC06/27/2026SE
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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
K241170Dynamic TiBase; TRI ScrewsNHA · Traditional 10/21/2024SE
K231559Multi-Unit DAS SystemNHA · Traditional 11/17/2023SE
K212108Dynamic TiBaseNHA · Traditional 09/24/2021SE

Questions and answers

When was Dynamic TiBase cleared by the FDA?

Dynamic TiBase (K232151) received a 510(k) decision of Substantially Equivalent on October 17, 2023, 90 days after the submission was received.

What is the product code of K232151?

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