Fit SA
Material, Tooth Shade, Resin
Shofu Dental Corporation
The following data is part of a premarket notification filed by Shofu Dental Corporation with the FDA for Fit Sa.
Pre-market Notification Details
| Device ID | K182869 |
| 510k Number | K182869 |
| Device Name: | Fit SA |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Shofu Dental Corporation 1225 Stone Drive San Marcos, CA 92078 |
| Contact | Mauro Malzyner |
| Correspondent | Mauro Malzyner Shofu Dental Corporation 1225 Stone Drive San Marcos, CA 92078 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-12 |
| Decision Date | 2019-01-09 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E235Y25640 | K182869 | 000 |
| E235Y10140 | K182869 | 000 |
| E235Y10120 | K182869 | 000 |
| E235Y10110 | K182869 | 000 |
| E235Y25440 | K182869 | 000 |
| E235Y25430 | K182869 | 000 |
| E235Y25420 | K182869 | 000 |
| E235Y25410 | K182869 | 000 |
| E235Y25400 | K182869 | 000 |
| 04548162310262 | K182869 | 000 |
| 04548162310255 | K182869 | 000 |
| 04548162310231 | K182869 | 000 |
| E235Y10150 | K182869 | 000 |
| E235Y25680 | K182869 | 000 |
| E235Y25690 | K182869 | 000 |
| E235Y25630 | K182869 | 000 |
| E235Y25620 | K182869 | 000 |
| E235Y25610 | K182869 | 000 |
| E235Y25600 | K182869 | 000 |
| E235Y25540 | K182869 | 000 |
| E235Y25530 | K182869 | 000 |
| E235Y25520 | K182869 | 000 |
| E235Y25510 | K182869 | 000 |
| E235Y25500 | K182869 | 000 |
| E235Y25720 | K182869 | 000 |
| E235Y25710 | K182869 | 000 |
| 04548162310224 | K182869 | 000 |
Trademark Results [Fit SA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FIT SA 88086579 not registered Live/Pending |
SHOFU, INC. 2018-08-21 |
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