The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Lite Art.
| Device ID | K101621 |
| 510k Number | K101621 |
| Device Name: | LITE ART |
| Classification | Material, Tooth Shade, Resin |
| Applicant | SHOFU DENTAL CORP. 1225 STONE DR. San Marcos, CA 92078 |
| Contact | David P Morais |
| Correspondent | David P Morais SHOFU DENTAL CORP. 1225 STONE DR. 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 | 2010-06-09 |
| Decision Date | 2010-08-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E23519860 | K101621 | 000 |
| E23519710 | K101621 | 000 |
| E23519720 | K101621 | 000 |
| E23519730 | K101621 | 000 |
| E23519740 | K101621 | 000 |
| E23519750 | K101621 | 000 |
| E23519760 | K101621 | 000 |
| E23519770 | K101621 | 000 |
| E23519780 | K101621 | 000 |
| E23519790 | K101621 | 000 |
| E23519800 | K101621 | 000 |
| E23519810 | K101621 | 000 |
| E23519820 | K101621 | 000 |
| E23519830 | K101621 | 000 |
| E23519840 | K101621 | 000 |
| E23519850 | K101621 | 000 |
| E23519700 | K101621 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LITE ART 77881217 3932173 Live/Registered |
Shofu, Inc. 2009-11-25 |