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 |