The following data is part of a premarket notification filed by Kerr Corporation with the FDA for Endovac Pure.
Device ID | K162436 |
510k Number | K162436 |
Device Name: | EndoVac Pure |
Classification | Handpiece, Air-powered, Root Canal Irrigation |
Applicant | Kerr Corporation 1717 W. Collins Ave Orange, CA 92867 |
Contact | Mohammad Saad Ansari |
Correspondent | Mohammad Saad Ansari Sybron Dental Specialties 1717 W. Collins Ave Orange, CA 92867 |
Product Code | NYL |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-08-31 |
Decision Date | 2016-12-21 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ENDOVAC PURE 87320119 5476505 Live/Registered |
Ormco Corporation 2017-01-31 |