The following data is part of a premarket notification filed by Tokuyama America, Inc. with the FDA for Palfique Light Bonding Agent.
| Device ID | K897009 |
| 510k Number | K897009 |
| Device Name: | PALFIQUE LIGHT BONDING AGENT |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | TOKUYAMA AMERICA, INC. 2000 M ST. NW SUITE 700 Washington, DC 20036 |
| Contact | Emalee G Murphy |
| Correspondent | Emalee G Murphy TOKUYAMA AMERICA, INC. 2000 M ST. NW 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 | 1989-12-13 |
| Decision Date | 1990-05-15 |