The following data is part of a premarket notification filed by Mti Precision Products with the FDA for Lynx Dpa Disposable Prophy Angle.
Device ID | K960541 |
510k Number | K960541 |
Device Name: | LYNX DPA DISPOSABLE PROPHY ANGLE |
Classification | Handpiece, Air-powered, Dental |
Applicant | MTI PRECISION PRODUCTS 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
Contact | Anne Marie Cesario |
Correspondent | Anne Marie Cesario MTI PRECISION PRODUCTS 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
Product Code | EFB |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-02-07 |
Decision Date | 1996-03-28 |