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FDA 510(k)

Dentium Ti-Base

K-Number: K171622 · 2018-01-11

ApplicantDentium Co., Ltd.
Decision Date2018-01-11
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dentium Ti-Base is the device name listed in this FDA 510(k) record. The listed applicant is Dentium Co., Ltd.. It received FDA 510(k) clearance on 2018-01-11 under 510(k) number K171622. 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 Dentium Ti-Base?

Dentium Ti-Base is a medical device that received FDA 510(k) clearance on 2018-01-11. The listed applicant is Dentium Co., Ltd.. The 510(k) number is K171622.

When did Dentium Ti-Base receive FDA 510(k) clearance?

Dentium Ti-Base received FDA 510(k) clearance on 2018-01-11, under 510(k) number K171622.

Who is the listed applicant for Dentium Ti-Base?

The FDA 510(k) record lists Dentium Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dentium Ti-Base?

The FDA product code for Dentium Ti-Base is NHA.

Other records listing Dentium Co., Ltd. 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.

K213599SuperLineK193341iCTmotor (WL-1)K192436Healing Abutments and Cover ScrewsK191634Scan Abutments and Comfort CapsK172640Dentium Implantium & SuperLine ProstheticsK171126Implantium II

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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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