The following data is part of a premarket notification filed by Williams Dental Co., Inc. with the FDA for Heliomolar(r) Dental Restorative.
| Device ID | K884588 |
| 510k Number | K884588 |
| Device Name: | HELIOMOLAR(R) DENTAL RESTORATIVE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | WILLIAMS DENTAL CO., INC. 2948 MAIN ST. Buffalo, NY 14214 |
| Contact | Gary L Severance |
| Correspondent | Gary L Severance WILLIAMS DENTAL CO., INC. 2948 MAIN ST. Buffalo, NY 14214 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-02 |
| Decision Date | 1989-01-27 |