The following data is part of a premarket notification filed by Ivoclar Vivadent Ag with the FDA for Adhese Universal.
| Device ID | K133318 |
| 510k Number | K133318 |
| Device Name: | ADHESE UNIVERSAL |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | IVOCLAR VIVADENT AG 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Donna Hartnett |
| Correspondent | Donna Hartnett IVOCLAR VIVADENT AG 175 PINEVIEW DR. Amherst, NY 14228 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-28 |
| Decision Date | 2014-02-11 |
| Summary: | summary |