The following data is part of a premarket notification filed by Parexel Intl. Corp. with the FDA for Natura-dent Vacuum-fired Porcelain Teeth.
| Device ID | K841826 |
| 510k Number | K841826 |
| Device Name: | NATURA-DENT VACUUM-FIRED PORCELAIN TEETH |
| Classification | Teeth, Porcelain |
| Applicant | PAREXEL INTL. 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 | 1984-05-02 |
| Decision Date | 1984-07-12 |