The following data is part of a premarket notification filed by Sagemax Bioceramics, Inc. with the FDA for Nexxzr(tm)t And Nexxzr(tm)s.
| Device ID | K130991 |
| 510k Number | K130991 |
| Device Name: | NEXXZR(TM)T AND NEXXZR(TM)S |
| Classification | Powder, Porcelain |
| Applicant | SAGEMAX BIOCERAMICS, INC. 34210 9th Ave S Suite 118 Federal Way, WA 98003 |
| Contact | Jose E Cabrera |
| Correspondent | Jose E Cabrera SAGEMAX BIOCERAMICS, INC. 34210 9th Ave S Suite 118 Federal Way, WA 98003 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-10 |
| Decision Date | 2014-02-10 |
| Summary: | summary |