The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for Heliomolar Hb Translucent Shades.
| Device ID | K013929 |
| 510k Number | K013929 |
| Device Name: | HELIOMOLAR HB TRANSLUCENT SHADES |
| Classification | Material, Tooth Shade, Resin |
| Applicant | IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Donna M Hartnett |
| Correspondent | Donna M Hartnett IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-28 |
| Decision Date | 2002-02-07 |