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FDA 510(k)

Dynamic TiBase

K-Number: K212108 · 2021-09-24

ApplicantTalladium España, SL
Decision Date2021-09-24
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dynamic TiBase is the device name listed in this FDA 510(k) record. The listed applicant is Talladium España, SL. It received FDA 510(k) clearance on 2021-09-24 under 510(k) number K212108. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dynamic TiBase?

Dynamic TiBase is a medical device that received FDA 510(k) clearance on 2021-09-24. The listed applicant is Talladium España, SL. The 510(k) number is K212108.

When did Dynamic TiBase receive FDA 510(k) clearance?

Dynamic TiBase received FDA 510(k) clearance on 2021-09-24, under 510(k) number K212108.

Who is the listed applicant for Dynamic TiBase?

The FDA 510(k) record lists Talladium España, SL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dynamic TiBase?

The FDA product code for Dynamic TiBase is NHA.

Other records listing Talladium España, SL as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243732Multi-Unit DAS SystemK243425Guided DAS Surgical KitK243530Dynamic TiBaseK241170Dynamic TiBase; TRI ScrewsK231559Multi-Unit DAS SystemK232151Dynamic TiBase

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Related Devices (Code: NHA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare ABK261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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