The following data is part of a premarket notification filed by Ivoclar Vivadent Ag with the FDA for Sr Nexco Paste Layering Materials, Sr Nexco Opaquer, Sr Nexco Liner-sr Nexco Connect, Sr Nexco Stains, Sr Nexco Retentio.
| Device ID | K123304 |
| 510k Number | K123304 |
| Device Name: | SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO CONNECT, SR NEXCO STAINS, SR NEXCO RETENTIO |
| Classification | Material, Tooth Shade, Resin |
| Applicant | IVOCLAR VIVADENT AG 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Donna M Hartnett |
| Correspondent | Donna M Hartnett IVOCLAR VIVADENT AG 175 PINEVIEW DR. Amherst, NY 14228 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-24 |
| Decision Date | 2013-01-24 |