The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Beautifil Flow Plus.
Device ID | K101603 |
510k Number | K101603 |
Device Name: | BEAUTIFIL FLOW PLUS |
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 | 2010-06-08 |
Decision Date | 2010-08-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
E23520000 | K101603 | 000 |
E23520160 | K101603 | 000 |
E23520170 | K101603 | 000 |
E23520180 | K101603 | 000 |
E23520200 | K101603 | 000 |
E23520210 | K101603 | 000 |
E23520230 | K101603 | 000 |
E23520240 | K101603 | 000 |
E23520260 | K101603 | 000 |
E23520270 | K101603 | 000 |
E23522000 | K101603 | 000 |
E23522010 | K101603 | 000 |
E23520150 | K101603 | 000 |
E23520140 | K101603 | 000 |
E23520130 | K101603 | 000 |
E23520010 | K101603 | 000 |
E23520020 | K101603 | 000 |
E2352002B0 | K101603 | 000 |
E23520030 | K101603 | 000 |
E23520040 | K101603 | 000 |
E23520050 | K101603 | 000 |
E23520060 | K101603 | 000 |
E23520070 | K101603 | 000 |
E23520080 | K101603 | 000 |
E23520100 | K101603 | 000 |
E23520110 | K101603 | 000 |
E23522020 | K101603 | 000 |
E23522030 | K101603 | 000 |
E23522040 | K101603 | 000 |
E23522220 | K101603 | 000 |
E23522230 | K101603 | 000 |
E23522240 | K101603 | 000 |
E23522250 | K101603 | 000 |
E23522260 | K101603 | 000 |
E23522270 | K101603 | 000 |
E23522290 | K101603 | 000 |
E23522300 | K101603 | 000 |
E23522320 | K101603 | 000 |
E23522330 | K101603 | 000 |
E23522350 | K101603 | 000 |
E23522210 | K101603 | 000 |
E23522200 | K101603 | 000 |
E23522190 | K101603 | 000 |
E23522050 | K101603 | 000 |
E23522060 | K101603 | 000 |
E23522070 | K101603 | 000 |
E23522080 | K101603 | 000 |
E23522090 | K101603 | 000 |
E23522110 | K101603 | 000 |
E23522120 | K101603 | 000 |
E23522130 | K101603 | 000 |
E23522150 | K101603 | 000 |
E23522160 | K101603 | 000 |
E23522180 | K101603 | 000 |
E23522360 | K101603 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BEAUTIFIL FLOW PLUS 85211406 4009208 Live/Registered |
Shofu, Inc. 2011-01-05 |