The following data is part of a premarket notification filed by Wright Health Group Ltd. with the FDA for Dentavit, Monarch, Acrotone, Senator, Dentorium.
| Device ID | K122955 |
| 510k Number | K122955 |
| Device Name: | DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM |
| Classification | Denture, Plastic, Teeth |
| Applicant | WRIGHT HEALTH GROUP LTD. 30 NORTHPORT ROAD Sound Beach, NY 11764 |
| Contact | Stephen T Mlcoch |
| Correspondent | Stephen T Mlcoch WRIGHT HEALTH GROUP LTD. 30 NORTHPORT ROAD Sound Beach, NY 11764 |
| Product Code | ELM |
| CFR Regulation Number | 872.3590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-25 |
| Decision Date | 2013-03-01 |
| Summary: | summary |