The following data is part of a premarket notification filed by Claronav Inc. with the FDA for Navident.
Device ID | K161406 |
510k Number | K161406 |
Device Name: | Navident |
Classification | Dental Stereotaxic Instrument |
Applicant | ClaroNav Inc. 1140 Sheppard Avenue West, Unit 10 Toronto, CA M3k 2a2 |
Contact | Doron Dekel |
Correspondent | Doron Dekel ClaroNav Inc. 1140 Sheppard Avenue West, Unit 10 Toronto, CA M3k 2a2 |
Product Code | PLV |
CFR Regulation Number | 872.4120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-05-20 |
Decision Date | 2016-09-08 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07540209990021 | K161406 | 000 |
07540209990014 | K161406 | 000 |
07540209955044 | K161406 | 000 |
07540209955037 | K161406 | 000 |
07540209955006 | K161406 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NAVIDENT 97284702 not registered Live/Pending |
ClaroNav Inc. 2022-02-25 |
NAVIDENT 88289942 not registered Dead/Abandoned |
Dent Group LLC 2019-02-05 |
NAVIDENT 85683775 not registered Dead/Abandoned |
Claron Technology Inc 2012-07-23 |