The following data is part of a premarket notification filed by Myerson Tooth Corp. with the FDA for Myerson R&kenson R Porcelain Ant&pos.-.
| Device ID | K800829 |
| 510k Number | K800829 |
| Device Name: | MYERSON R&KENSON R PORCELAIN ANT&POS.- |
| Classification | Teeth, Porcelain |
| Applicant | MYERSON TOOTH CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ELL |
| CFR Regulation Number | 872.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-14 |
| Decision Date | 1980-05-08 |