The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Ortho Wax.
| Device ID | K924024 |
| 510k Number | K924024 |
| Device Name: | ORTHO WAX |
| Classification | Wax, Dental, Intraoral |
| 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 | EGD |
| CFR Regulation Number | 872.6890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-11 |
| Decision Date | 1992-11-17 |