The following data is part of a premarket notification filed by Polident D.o.o., Dental Products Industry with the FDA for Pink Cad/cam Disc.
| Device ID | K153546 |
| 510k Number | K153546 |
| Device Name: | PINK CAD/CAM Disc |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| 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 | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-11 |
| Decision Date | 2016-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EPOLPMMP10091 | K153546 | 000 |
| EPOLPMMP10231 | K153546 | 000 |
| EPOLPMMP10241 | K153546 | 000 |
| EPOLPMMP10251 | K153546 | 000 |
| EPOLPMMP4811 | K153546 | 000 |
| EPOLPMMP4821 | K153546 | 000 |
| EPOLPMMP4831 | K153546 | 000 |
| EPOLPMMP4881 | K153546 | 000 |
| EPOLPMMP4891 | K153546 | 000 |
| EPOLPMMP4901 | K153546 | 000 |
| EPOLPMMP5111 | K153546 | 000 |
| EPOLPMMP10221 | K153546 | 000 |
| EPOLPMMP10211 | K153546 | 000 |
| EPOLPMMP10201 | K153546 | 000 |
| EPOLPMMP10101 | K153546 | 000 |
| EPOLPMMP10111 | K153546 | 000 |
| EPOLPMMP10121 | K153546 | 000 |
| EPOLPMMP10131 | K153546 | 000 |
| EPOLPMMP10141 | K153546 | 000 |
| EPOLPMMP10151 | K153546 | 000 |
| EPOLPMMP10161 | K153546 | 000 |
| EPOLPMMP10171 | K153546 | 000 |
| EPOLPMMP10181 | K153546 | 000 |
| EPOLPMMP10191 | K153546 | 000 |
| EPOLPMMP6601 | K153546 | 000 |
| EPOLPMMP6621 | K153546 | 000 |
| EPOLPMMP6751 | K153546 | 000 |
| EPOLPMMP48303 | K153546 | 000 |
| EPOLPMMP48403 | K153546 | 000 |
| EPOLPMMP48503 | K153546 | 000 |
| EPOLPMMP48603 | K153546 | 000 |
| EPOLPMMP48703 | K153546 | 000 |
| EPOLPMMP48803 | K153546 | 000 |
| EPOLPMMP48903 | K153546 | 000 |
| EPOLPMMP49003 | K153546 | 000 |
| EPOLPMMP66003 | K153546 | 000 |
| EPOLPMMP66203 | K153546 | 000 |
| EPOLPMMP48203 | K153546 | 000 |
| EPOLPMMP48103 | K153546 | 000 |
| EPOLPMMPML3571 | K153546 | 000 |
| EPOLPMMP6771 | K153546 | 000 |
| EPOLPMMP6781 | K153546 | 000 |
| EPOLPMMP6791 | K153546 | 000 |
| EPOLPMMP7831 | K153546 | 000 |
| EPOLPMMP7841 | K153546 | 000 |
| EPOLPMMP7851 | K153546 | 000 |
| EPOLPMMP7861 | K153546 | 000 |
| EPOLPMMP7871 | K153546 | 000 |
| EPOLPMMP7881 | K153546 | 000 |
| EPOLPMMPML3561 | K153546 | 000 |
| EPOLPMMP67903 | K153546 | 000 |