The following data is part of a premarket notification filed by Zhermack S.p.a. with the FDA for Neocolloid, Orthoprint.
| Device ID | K981091 |
| 510k Number | K981091 |
| Device Name: | NEOCOLLOID, ORTHOPRINT |
| Classification | Material, Impression |
| Applicant | ZHERMACK S.P.A. 7527 WESTMORELAND AVE. St. Louis, MO 63105 |
| Contact | Evan Dick |
| Correspondent | Evan Dick ZHERMACK S.P.A. 7527 WESTMORELAND AVE. St. Louis, MO 63105 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-25 |
| Decision Date | 1998-05-21 |