The following data is part of a premarket notification filed by Lee Pharmaceuticals with the FDA for Cleanse N Bond I.
| Device ID | K844133 |
| 510k Number | K844133 |
| Device Name: | CLEANSE N BOND I |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | LEE PHARMACEUTICALS 1444 SANTA ANITA P.O. BOX 3836 South El Monte, CA 91733 |
| Contact | Dian Teigler |
| Correspondent | Dian Teigler LEE PHARMACEUTICALS 1444 SANTA ANITA P.O. BOX 3836 South El Monte, CA 91733 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-23 |
| Decision Date | 1985-01-04 |