The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Fermit Plus.
| Device ID | K003374 |
| 510k Number | K003374 |
| Device Name: | FERMIT PLUS |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Andy Gulati |
| Correspondent | Andy Gulati IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-30 |
| Decision Date | 2000-12-04 |