The following data is part of a premarket notification filed by Modern Materials with the FDA for Steele's Econ. Pink Basepl. Waxes, I-iii.
| Device ID | K812805 |
| 510k Number | K812805 |
| Device Name: | STEELE'S ECON. PINK BASEPL. WAXES, I-III |
| Classification | Wax, Dental, Intraoral |
| Applicant | MODERN MATERIALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EGD |
| CFR Regulation Number | 872.6890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-06 |
| Decision Date | 1982-01-12 |