MIS CONNECT Conical Connection Abutment

FDA 510(k) K173326 · Mis Implants Technologies , Ltd.

Substantially Equivalent

510(k) numberK173326

Submission

Device name
MIS CONNECT Conical Connection Abutment
Applicant
Mis Implants Technologies , Ltd.
Bar Lev Industrial Park, IL
Received
October 20, 2017
Decision date
March 16, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NHA – Abutment, Implant, Dental, Endosseous
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3630
Specialty
Dental
Implant
Yes

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

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Questions and answers

When was MIS CONNECT Conical Connection Abutment cleared by the FDA?

MIS CONNECT Conical Connection Abutment (K173326) received a 510(k) decision of Substantially Equivalent on March 16, 2018, 147 days after the submission was received.

What is the product code of K173326?

The FDA product code is NHA – Abutment, Implant, Dental, Endosseous, a Class II (moderate risk) device regulated under 21 CFR 872.3630.