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 |