The following data is part of a premarket notification filed by Lee Pharmaceuticals with the FDA for Restobond 3/dentin-enamel Bonding Agent.
| Device ID | K894315 |
| 510k Number | K894315 |
| Device Name: | RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | LEE PHARMACEUTICALS 1444 SANTA ANITA P.O. BOX 3836 South El Monte, CA 91733 |
| Contact | Teigler, Ph.d. |
| Correspondent | Teigler, Ph.d. LEE PHARMACEUTICALS 1444 SANTA ANITA P.O. BOX 3836 South El Monte, CA 91733 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-14 |
| Decision Date | 1989-10-31 |