The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Xantopren Comfort.
| Device ID | K991425 |
| 510k Number | K991425 |
| Device Name: | XANTOPREN COMFORT |
| Classification | Material, Impression |
| Applicant | HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614 -2517 |
| Contact | Cheryl V Zimmerman |
| Correspondent | Cheryl V Zimmerman HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614 -2517 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-23 |
| Decision Date | 1999-06-15 |
| Summary: | summary |