The following data is part of a premarket notification filed by Dentatus Usa, Ltd. with the FDA for Mti-mp Transitional Implants And Modular Prosthetic System.
Device ID | K961704 |
510k Number | K961704 |
Device Name: | MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM |
Classification | Splint, Endodontic Stabilizing |
Applicant | DENTATUS USA, LTD. 192 LEXINGTON AVE. New York, NY 10016 |
Contact | Stephen B Rubinsky |
Correspondent | Stephen B Rubinsky DENTATUS USA, LTD. 192 LEXINGTON AVE. New York, NY 10016 |
Product Code | ELS |
CFR Regulation Number | 872.3890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-05-02 |
Decision Date | 1996-07-26 |
Summary: | summary |