The following data is part of a premarket notification filed by Nobio Ltd. with the FDA for Novidia Flowable Composite.
Device ID | K182580 |
510k Number | K182580 |
Device Name: | Novidia Flowable Composite |
Classification | Material, Tooth Shade, Resin |
Applicant | Nobio Ltd. 20 Hamagshimim St. Petach Tikva, IL 4934829 |
Contact | Inbal Beinglass Peled |
Correspondent | Shoshanna (shosh) Friedman ProMedoss, Inc. 3521 Hatwynn Rd. Charlotte, NC 28269 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-09-19 |
Decision Date | 2019-07-03 |