The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for Condylaform Ii Nfc.
| Device ID | K060565 |
| 510k Number | K060565 |
| Device Name: | CONDYLAFORM II NFC |
| Classification | Denture, Plastic, Teeth |
| Applicant | IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Donna M Hartnett |
| Correspondent | Donna M Hartnett IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Product Code | ELM |
| CFR Regulation Number | 872.3590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-03 |
| Decision Date | 2006-05-08 |
| Summary: | summary |