The following data is part of a premarket notification filed by M&m Dental Studio Inc with the FDA for Zx-27.
| Device ID | K133088 |
| 510k Number | K133088 |
| Device Name: | ZX-27 |
| Classification | Anchor, Preformed |
| Applicant | M&M DENTAL STUDIO INC 420 LEXINGTON AVE SUITE 2400 New York, NY 10170 |
| Contact | Irving Wiesen |
| Correspondent | Irving Wiesen M&M DENTAL STUDIO INC 420 LEXINGTON AVE SUITE 2400 New York, NY 10170 |
| Product Code | EJX |
| CFR Regulation Number | 872.3130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-30 |
| Decision Date | 2015-01-02 |