The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for Sr Vivodent S, Sr Orthotyp S, Sr Ortholingual S.
| Device ID | K132984 |
| 510k Number | K132984 |
| Device Name: | SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S |
| Classification | Denture, Plastic, Teeth |
| Applicant | IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Donna Marie Hartnett |
| Correspondent | Donna Marie 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 | 2013-09-24 |
| Decision Date | 2014-01-14 |
| Summary: | summary |