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FDA 510(k)

Transfer & Angled Abutment

K-Number: K153015 · 2016-12-05

ApplicantOsstem Implant Co., Ltd.
Decision Date2016-12-05
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Transfer & Angled Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2016-12-05 under 510(k) number K153015. 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 Transfer & Angled Abutment?

Transfer & Angled Abutment is a medical device that received FDA 510(k) clearance on 2016-12-05. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K153015.

When did Transfer & Angled Abutment receive FDA 510(k) clearance?

Transfer & Angled Abutment received FDA 510(k) clearance on 2016-12-05, under 510(k) number K153015.

Who is the listed applicant for Transfer & Angled Abutment?

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

What is the FDA product code for Transfer & Angled Abutment?

The FDA product code for Transfer & Angled Abutment is NHA.

Other records listing Osstem Implant 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.

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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.

K261147Neodent 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, LLCK260564DESS Dental Smart SolutionsTerrats Medical SL

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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