The following data is part of a premarket notification filed by Afp Imaging Corp. with the FDA for Extoral/tescera Glazing Resin, Model T-1804.
| Device ID | K014144 |
| 510k Number | K014144 |
| Device Name: | EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804 |
| Classification | Material, Tooth Shade, Resin |
| Applicant | AFP IMAGING CORP. 250 CLEARBROOK RD. Elmsford, NY 10523 |
| Contact | David Vozick |
| Correspondent | David Vozick AFP IMAGING CORP. 250 CLEARBROOK RD. Elmsford, NY 10523 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-18 |
| Decision Date | 2002-02-07 |
| Summary: | summary |