The following data is part of a premarket notification filed by Nobio Ltd. with the FDA for Novidia Universal Bond.
Device ID | K183391 |
510k Number | K183391 |
Device Name: | Novidia Universal Bond |
Classification | Agent, Tooth Bonding, Resin |
Applicant | Nobio Ltd. 8 Hamatechet St. Kadima, IL 6092000 |
Contact | Inbal Beinglass Peled |
Correspondent | Shoshana (shosh) Friedman Nobio [c/o ProMedoss, Inc.] 3521 Hatwynn Rd. Charlotte, NC 28269 |
Product Code | KLE |
CFR Regulation Number | 872.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-12-07 |
Decision Date | 2019-09-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07290017528342 | K183391 | 000 |
17290017528370 | K183391 | 000 |
07290017528304 | K183391 | 000 |
07290017528298 | K183391 | 000 |