The following data is part of a premarket notification filed by Lee Pharmaceuticals with the FDA for Precise(r) Beta Quartz Glass-ceramic Insert.
| Device ID | K912256 |
| 510k Number | K912256 |
| Device Name: | PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | LEE PHARMACEUTICALS 1444 SANTA ANITA P.O. BOX 3836 South El Monte, CA 91733 |
| Contact | Amin Hasham |
| Correspondent | Amin Hasham 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 | 1991-05-22 |
| Decision Date | 1991-07-24 |