T.A.G. Dental Implant System

FDA 510(k) K143326 · T.A.G. Medical Products Corporation, Ltd.

Substantially Equivalent

510(k) numberK143326

Submission

Device name
T.A.G. Dental Implant System
Applicant
T.A.G. Medical Products Corporation, Ltd.
Kibbutz Gatton, IL
Received
November 20, 2014
Decision date
May 14, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DZE – Implant, Endosseous, Root-Form
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3640
Specialty
Dental
Implant
Yes

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Questions and answers

When was T.A.G. Dental Implant System cleared by the FDA?

T.A.G. Dental Implant System (K143326) received a 510(k) decision of Substantially Equivalent on May 14, 2015, 175 days after the submission was received.

What is the product code of K143326?

The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.