The following data is part of a premarket notification filed by Kuraray Medical Kurashiki Plant with the FDA for Clearfil Tri-s Bond Single Dose.
| Device ID | K051796 |
| 510k Number | K051796 |
| Device Name: | CLEARFIL TRI-S BOND SINGLE DOSE |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | KURARAY MEDICAL KURASHIKI PLANT 101 EAST 52ND STREET 26TH FLOOR New York, NY 10022 |
| Contact | Satoshi Yamaguchi |
| Correspondent | Satoshi Yamaguchi KURARAY MEDICAL KURASHIKI PLANT 101 EAST 52ND STREET 26TH FLOOR New York, NY 10022 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-05 |
| Decision Date | 2005-08-09 |
| Summary: | summary |