The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Solitaire 2.
| Device ID | K993932 |
| 510k Number | K993932 |
| Device Name: | SOLITAIRE 2 |
| Classification | Material, Tooth Shade, Resin |
| Applicant | HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614 |
| Contact | Cheryl V Zimmerman |
| Correspondent | Cheryl V Zimmerman HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-18 |
| Decision Date | 1999-12-22 |