The following data is part of a premarket notification filed by New Stetic S.a. with the FDA for Portux Cad/cam Disc.
| Device ID | K192153 |
| 510k Number | K192153 |
| Device Name: | Portux CAD/CAM Disc |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | New Stetic S.A. Carrera 53 No. 50 - 09 Guarne - Antioquia, CO |
| Contact | Juan David Jaramillo G. |
| Correspondent | Chris Brown Aclivi Consulting 6455 Farley Road Pinckney, MI 48169 |
| Product Code | EBG |
| Subsequent Product Code | EBI |
| Subsequent Product Code | MQC |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-09 |
| Decision Date | 2019-11-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E235D25BL4MN0 | K192153 | 000 |
| E235D20D2MN0 | K192153 | 000 |
| E235D20D2ML0 | K192153 | 000 |
| E235D20CC0 | K192153 | 000 |
| E235D20C2MN0 | K192153 | 000 |
| E235D20C2ML0 | K192153 | 000 |
| E235D20C1MN0 | K192153 | 000 |
| E235D20C1ML0 | K192153 | 000 |
| E235D20BLMN0 | K192153 | 000 |
| E235D20BLML0 | K192153 | 000 |
| E235D20BL4MN0 | K192153 | 000 |
| E235D20BL3MN0 | K192153 | 000 |
| E235D20BL3ML0 | K192153 | 000 |
| E235D20BL2MN0 | K192153 | 000 |
| E235D20BL1MN0 | K192153 | 000 |
| E235D20B3MN0 | K192153 | 000 |
| E235D20D3MN0 | K192153 | 000 |
| E235D20RC0 | K192153 | 000 |
| E235D25BL3MN0 | K192153 | 000 |
| E235D25BL3ML0 | K192153 | 000 |
| E235D25BL2MN0 | K192153 | 000 |
| E235D25BL1MN0 | K192153 | 000 |
| E235D25B3MN0 | K192153 | 000 |
| E235D25B2MN0 | K192153 | 000 |
| E235D25B2ML0 | K192153 | 000 |
| E235D25B1MN0 | K192153 | 000 |
| E235D25B1ML0 | K192153 | 000 |
| E235D25A3MN0 | K192153 | 000 |
| E235D25A3ML0 | K192153 | 000 |
| E235D25A35MN0 | K192153 | 000 |
| E235D25A35ML0 | K192153 | 000 |
| E235D25A2ML0 | K192153 | 000 |
| E235D25A1ML0 | K192153 | 000 |
| E235D20B2MN0 | K192153 | 000 |
| E235D20B2ML0 | K192153 | 000 |
| E235D18BL4MN0 | K192153 | 000 |
| E235D18BL3MN0 | K192153 | 000 |
| E235D18BL3ML0 | K192153 | 000 |
| E235D18BL2MN0 | K192153 | 000 |
| E235D18BL1MN0 | K192153 | 000 |
| E235D18B3MN0 | K192153 | 000 |
| E235D18B2MN0 | K192153 | 000 |
| E235D18B2ML0 | K192153 | 000 |
| E235D18B1ML0 | K192153 | 000 |
| E235D18A3MN0 | K192153 | 000 |
| E235D18A3ML0 | K192153 | 000 |
| E235D18A35MN0 | K192153 | 000 |
| E235D18A2MN0 | K192153 | 000 |
| E235D18A2ML0 | K192153 | 000 |
| E235D18A1MN0 | K192153 | 000 |
| E235D18BLML0 | K192153 | 000 |
| E235D18BLMN0 | K192153 | 000 |
| E235D20B1ML0 | K192153 | 000 |
| E235D20A3MN0 | K192153 | 000 |
| E235D20A3ML0 | K192153 | 000 |
| E235D20A35MN0 | K192153 | 000 |
| E235D20A35ML0 | K192153 | 000 |
| E235D20A2MN0 | K192153 | 000 |
| E235D20A2ML0 | K192153 | 000 |
| E235D20A1ML0 | K192153 | 000 |
| E235D18D3MN0 | K192153 | 000 |
| E235D18D2MN0 | K192153 | 000 |
| E235D18D2ML0 | K192153 | 000 |
| E235D18C2MN0 | K192153 | 000 |
| E235D18C2ML0 | K192153 | 000 |
| E235D18C1MN0 | K192153 | 000 |
| E235D18C1ML0 | K192153 | 000 |
| E235D18A1ML0 | K192153 | 000 |
| 07701126712350 | K192153 | 000 |
| 07701126712084 | K192153 | 000 |
| 07701126712077 | K192153 | 000 |
| 07701126711957 | K192153 | 000 |
| 07701126711681 | K192153 | 000 |
| 07701126711278 | K192153 | 000 |
| 07701126712060 | K192153 | 000 |
| 07701126713494 | K192153 | 000 |
| E235D35OB0 | K192153 | 000 |
| E235D35MB0 | K192153 | 000 |
| E235D35BLMN0 | K192153 | 000 |
| E235D35BLML0 | K192153 | 000 |
| E235D35BL4MN0 | K192153 | 000 |
| E235D35BL3MN0 | K192153 | 000 |
| E235D35BL3ML0 | K192153 | 000 |
| E235D35BL2MN0 | K192153 | 000 |
| 07701126712107 | K192153 | 000 |
| 07701126712114 | K192153 | 000 |
| 07701126712343 | K192153 | 000 |
| 07701126712336 | K192153 | 000 |
| 07701126712329 | K192153 | 000 |
| 07701126712312 | K192153 | 000 |
| 07701126712305 | K192153 | 000 |
| 07701126712299 | K192153 | 000 |
| 07701126712282 | K192153 | 000 |
| 07701126712275 | K192153 | 000 |
| 07701126712244 | K192153 | 000 |
| 07701126712237 | K192153 | 000 |
| 07701126712220 | K192153 | 000 |
| 07701126712169 | K192153 | 000 |
| 07701126712152 | K192153 | 000 |
| 07701126712145 | K192153 | 000 |
| 07701126712121 | K192153 | 000 |
| E235D35BL1MN0 | K192153 | 000 |
| E235D35B2ML0 | K192153 | 000 |
| E235D30B2ML0 | K192153 | 000 |
| E235D30B1ML0 | K192153 | 000 |
| E235D30A3ML0 | K192153 | 000 |
| E235D30A2ML0 | K192153 | 000 |
| E235D30A1ML0 | K192153 | 000 |
| E235D25OB0 | K192153 | 000 |
| E235D25D3MN0 | K192153 | 000 |
| E235D25D2MN0 | K192153 | 000 |
| E235D25D2ML0 | K192153 | 000 |
| E235D25C3ML0 | K192153 | 000 |
| E235D25C2MN0 | K192153 | 000 |
| E235D25C2ML0 | K192153 | 000 |
| E235D25C1MN0 | K192153 | 000 |
| E235D25C1ML0 | K192153 | 000 |
| E235D25BLMN0 | K192153 | 000 |
| E235D30BL1MN0 | K192153 | 000 |
| E235D30BL2MN0 | K192153 | 000 |
| E235D35B1MN0 | K192153 | 000 |
| E235D35B1ML0 | K192153 | 000 |
| E235D35A3ML0 | K192153 | 000 |
| E235D35A2ML0 | K192153 | 000 |
| E235D35A1ML0 | K192153 | 000 |
| E235D30OB0 | K192153 | 000 |
| E235D30D2ML0 | K192153 | 000 |
| E235D30C3ML0 | K192153 | 000 |
| E235D30C2ML0 | K192153 | 000 |
| E235D30C1ML0 | K192153 | 000 |
| E235D30BLMN0 | K192153 | 000 |
| E235D30BLML0 | K192153 | 000 |
| E235D30BL4MN0 | K192153 | 000 |
| E235D30BL3MN0 | K192153 | 000 |
| E235D30BL3ML0 | K192153 | 000 |
| E235D25BLML0 | K192153 | 000 |