The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Versyo.com.
| Device ID | K010800 |
| 510k Number | K010800 |
| Device Name: | VERSYO.COM |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | HERAEUS KULZER, INC. 99 BUSINESS PARK DR. Armonk, NY 10504 |
| Contact | Raphael Judkins |
| Correspondent | Raphael Judkins HERAEUS KULZER, INC. 99 BUSINESS PARK DR. Armonk, NY 10504 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-16 |
| Decision Date | 2001-05-31 |