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FDA 510(k)

IS Multi Unit Abutment System

K-Number: K210903 · 2021-07-23

ApplicantNeobiotech Co., Ltd.
Decision Date2021-07-23
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IS Multi Unit Abutment System is a medical device manufactured by Neobiotech Co., Ltd.. It received FDA 510(k) clearance on 2021-07-23 under approval number K210903. 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 IS Multi Unit Abutment System?

IS Multi Unit Abutment System is a medical device that received FDA 510(k) clearance on 2021-07-23. It is manufactured by Neobiotech Co., Ltd.. The 510(k) number is K210903.

When was IS Multi Unit Abutment System approved by the FDA?

IS Multi Unit Abutment System received FDA 510(k) clearance on 2021-07-23, under approval number K210903.

What company makes IS Multi Unit Abutment System?

IS Multi Unit Abutment System is manufactured by Neobiotech Co., Ltd..

What is the FDA product code for IS Multi Unit Abutment System?

The FDA product code for IS Multi Unit Abutment System is NHA.

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026)

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Related Devices (Code: NHA)

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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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