Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Ni2 Implant System

K-Number: K221847 · 2024-04-11

ApplicantNewton Implant Systems, Inc.
Decision Date2024-04-11
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Ni2 Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Newton Implant Systems, Inc.. It received FDA 510(k) clearance on 2024-04-11 under 510(k) number K221847. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ni2 Implant System?

Ni2 Implant System is a medical device that received FDA 510(k) clearance on 2024-04-11. The listed applicant is Newton Implant Systems, Inc.. The 510(k) number is K221847.

When did Ni2 Implant System receive FDA 510(k) clearance?

Ni2 Implant System received FDA 510(k) clearance on 2024-04-11, under 510(k) number K221847.

Who is the listed applicant for Ni2 Implant System?

The FDA 510(k) record lists Newton Implant Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ni2 Implant System?

The FDA product code for Ni2 Implant System is DZE.

Other records listing Newton Implant Systems, Inc. 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.

K221866S-Plant Dental Implant System

Related Devices (Code: DZE)

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.

K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd.

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.

↑