The following data is part of a premarket notification filed by Nobio Ltd. with the FDA for Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite.
| Device ID | K201010 |
| 510k Number | K201010 |
| Device Name: | Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Nobio Ltd. 8 Hamatechet St. Kadima, IL 6092000 |
| Contact | Galit Gershon |
| Correspondent | Shoshan (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 | 2020-04-17 |
| Decision Date | 2020-08-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290017528434 | K201010 | 000 |
| 17290017528240 | K201010 | 000 |
| 07290017528205 | K201010 | 000 |
| 17290017528233 | K201010 | 000 |
| 17290017528158 | K201010 | 000 |
| 17290017528141 | K201010 | 000 |
| 17290017528134 | K201010 | 000 |
| 17290017528042 | K201010 | 000 |
| 17290017528035 | K201010 | 000 |
| 07290017528021 | K201010 | 000 |
| 17290017528011 | K201010 | 000 |
| 17290017528257 | K201010 | 000 |
| 17290017528424 | K201010 | 000 |
| 07290017528052 | K201010 | 000 |
| 07290017528281 | K201010 | 000 |
| 07290017528274 | K201010 | 000 |
| 07290017528267 | K201010 | 000 |
| 07290017528182 | K201010 | 000 |
| 07290017528175 | K201010 | 000 |
| 07290017528168 | K201010 | 000 |
| 07290017528090 | K201010 | 000 |
| 07290017528083 | K201010 | 000 |
| 07290017528076 | K201010 | 000 |
| 07290017528069 | K201010 | 000 |
| 17290017528004 | K201010 | 000 |