The following data is part of a premarket notification filed by Polident D.o.o., Dental Products Industry with the FDA for Pmma Cad/cam Disc.
| Device ID | K112967 |
| 510k Number | K112967 |
| Device Name: | PMMA CAD/CAM DISC |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY VOLCJA DRAGA 42 Volcja Draga, SI 5293 |
| Contact | Janja Lipuscek |
| Correspondent | Janja Lipuscek POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY VOLCJA DRAGA 42 Volcja Draga, SI 5293 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-05 |
| Decision Date | 2012-08-28 |
| Summary: | summary |