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 |
|---|---|---|
| 07701126712350 | K192153 | 000 |
| 07701126712152 | K192153 | 000 |
| 07701126712145 | K192153 | 000 |
| 07701126712121 | K192153 | 000 |
| 07701126712114 | K192153 | 000 |
| 07701126712107 | K192153 | 000 |
| 07701126712084 | K192153 | 000 |
| 07701126712077 | K192153 | 000 |
| 07701126711957 | K192153 | 000 |
| 07701126711681 | K192153 | 000 |
| 07701126711278 | K192153 | 000 |
| 07701126712169 | K192153 | 000 |
| 07701126712220 | 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 |
| 07701126712060 | K192153 | 000 |