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FDA 510(k)

Scan Abutments and Comfort Caps

K-Number: K191634 · 2019-11-04

ApplicantDentium Co., Ltd.
Decision Date2019-11-04
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Scan Abutments and Comfort Caps 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 2019-11-04 under 510(k) number K191634. 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 Scan Abutments and Comfort Caps?

Scan Abutments and Comfort Caps is a medical device that received FDA 510(k) clearance on 2019-11-04. The listed applicant is Dentium Co., Ltd.. The 510(k) number is K191634.

When did Scan Abutments and Comfort Caps receive FDA 510(k) clearance?

Scan Abutments and Comfort Caps received FDA 510(k) clearance on 2019-11-04, under 510(k) number K191634.

Who is the listed applicant for Scan Abutments and Comfort Caps?

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 Scan Abutments and Comfort Caps?

The FDA product code for Scan Abutments and Comfort Caps 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 ScrewsK172640Dentium Implantium & SuperLine ProstheticsK171622Dentium Ti-BaseK171126Implantium 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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