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

FDA 510(k)

MIS LOCKiT Abutments System, OT-Equators and Ball Attachments

K-Number: K182228 · 2019-01-28

ApplicantMis Implants Technologies , Ltd.
Decision Date2019-01-28
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MIS LOCKiT Abutments System, OT-Equators and Ball Attachments is a medical device manufactured by Mis Implants Technologies , Ltd.. It received FDA 510(k) clearance on 2019-01-28 under approval number K182228. 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 MIS LOCKiT Abutments System, OT-Equators and Ball Attachments?

MIS LOCKiT Abutments System, OT-Equators and Ball Attachments is a medical device that received FDA 510(k) clearance on 2019-01-28. It is manufactured by Mis Implants Technologies , Ltd.. The 510(k) number is K182228.

When was MIS LOCKiT Abutments System, OT-Equators and Ball Attachments approved by the FDA?

MIS LOCKiT Abutments System, OT-Equators and Ball Attachments received FDA 510(k) clearance on 2019-01-28, under approval number K182228.

What company makes MIS LOCKiT Abutments System, OT-Equators and Ball Attachments?

MIS LOCKiT Abutments System, OT-Equators and Ball Attachments is manufactured by Mis Implants Technologies , Ltd..

What is the FDA product code for MIS LOCKiT Abutments System, OT-Equators and Ball Attachments?

The FDA product code for MIS LOCKiT Abutments System, OT-Equators and Ball Attachments is NHA.

Related Clinical Trials

NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED

Other Devices by Mis Implants Technologies , Ltd.

K172505MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments K163349MIS V3 Conical Connection Dental Implant System­ K180282MIS Internal Hex Dental Implant System K173326MIS CONNECT Conical Connection Abutment

Related Devices (Code: NHA)

K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd. K160798IPS e.max® Press Abutment Solutions for Viteo Base TiIvoclar Vivadent, AG K162004PREMIUM Implant Systems SHELTA Implant SystemsSweden & Martina S.P.A. K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd. K161435Temporary Snap AbutmentNobel Biocare AB K160786RODO Abutment SystemRodo Medical, Inc.

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.

↑