The following data is part of a premarket notification filed by The Smylon Co. with the FDA for Smylon (dental Stain Eraser).
| Device ID | K891338 |
| 510k Number | K891338 |
| Device Name: | SMYLON (DENTAL STAIN ERASER) |
| Classification | Eraser, Dental Stain |
| Applicant | THE SMYLON CO. 7366 WARING AVE. Los Angeles, CA 90046 |
| Contact | Frank Coppola |
| Correspondent | Frank Coppola THE SMYLON CO. 7366 WARING AVE. Los Angeles, CA 90046 |
| Product Code | MAU |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-13 |
| Decision Date | 1989-11-14 |