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FDA 510(k)

s-Clean Pre-Milled Abutment Mini

K-Number: K210410 · 2021-09-10

ApplicantDentis Co., Ltd.
Decision Date2021-09-10
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

s-Clean Pre-Milled Abutment Mini is the device name listed in this FDA 510(k) record. The listed applicant is Dentis Co., Ltd.. It received FDA 510(k) clearance on 2021-09-10 under 510(k) number K210410. 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 s-Clean Pre-Milled Abutment Mini?

s-Clean Pre-Milled Abutment Mini is a medical device that received FDA 510(k) clearance on 2021-09-10. The listed applicant is Dentis Co., Ltd.. The 510(k) number is K210410.

When did s-Clean Pre-Milled Abutment Mini receive FDA 510(k) clearance?

s-Clean Pre-Milled Abutment Mini received FDA 510(k) clearance on 2021-09-10, under 510(k) number K210410.

Who is the listed applicant for s-Clean Pre-Milled Abutment Mini?

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

What is the FDA product code for s-Clean Pre-Milled Abutment Mini?

The FDA product code for s-Clean Pre-Milled Abutment Mini is NHA.

Other records listing Dentis 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.

K253493Dentis SQ-SL AXEL FixtureK241065ChecQ (AC100)K233921Luvis Chair (LC700C)K241063s-Clean ScanHealing AbutmentK240511Dentis s-Clean SQ-SL FixtureK233544MESHEET

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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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