The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for Sr Ivocron.
| Device ID | K013869 |
| 510k Number | K013869 |
| Device Name: | SR IVOCRON |
| Classification | Crown And Bridge, Temporary, Resin |
| 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 | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-21 |
| Decision Date | 2002-08-28 |