Cleared Traditional

MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM

K961704 · Dentatus USA , Ltd. · Dental

Jul 1996

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K961704 is an FDA 510(k) clearance for the MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM, a Splint, Endodontic Stabilizing (Class II — Special Controls, product code ELS), submitted by Dentatus USA , Ltd. (New York, US). The FDA issued a Cleared decision on July 26, 1996, 85 days after receiving the submission on May 2, 1996. This device falls under the Dental review panel. Regulated under 21 CFR 872.3890.

Submission Details

510(k) Number	K961704 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 02, 1996
Decision Date	July 26, 1996
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF