The following data is part of a premarket notification filed by Anaxdent Gmbh with the FDA for Anaxblend Model 20xxx (several), Anaxgum Model 25xxx (u), Mock-up Direct Model 240xxx (u), Mock-up Direct Flow Model 24a.
| Device ID | K112044 |
| 510k Number | K112044 |
| Device Name: | ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A |
| Classification | Material, Tooth Shade, Resin |
| Applicant | ANAXDENT GMBH 14500 FIM 470 Tarpley, TX 78883 |
| Contact | John Balistreri |
| Correspondent | John Balistreri ANAXDENT GMBH 14500 FIM 470 Tarpley, TX 78883 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-18 |
| Decision Date | 2012-01-26 |