The following data is part of a premarket notification filed by Tokuyama America, Inc. with the FDA for Tokuso Light Bond.
| Device ID | K911525 |
| 510k Number | K911525 |
| Device Name: | TOKUSO LIGHT BOND |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | TOKUYAMA AMERICA, INC. C/O GRAHAM & JAMES 2000 M STREET, N.W., SUITE 700 Washington, DC 20036 |
| Contact | Emalee G Murphy |
| Correspondent | Emalee G Murphy TOKUYAMA AMERICA, INC. C/O GRAHAM & JAMES 2000 M STREET, N.W., SUITE 700 Washington, DC 20036 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-05 |
| Decision Date | 1991-05-15 |