The following data is part of a premarket notification filed by Parexel Intl. Corp. with the FDA for Natura-tone Or Luxopal Cl Acrylic.
| Device ID | K842208 |
| 510k Number | K842208 |
| Device Name: | NATURA-TONE OR LUXOPAL CL ACRYLIC |
| Classification | Denture, Plastic, Teeth |
| Applicant | PAREXEL INTL. CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ELM |
| CFR Regulation Number | 872.3590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-04 |
| Decision Date | 1984-07-31 |