K181932 is an FDA 510(k) clearance for the DTX Studio design. This device is classified as a Dental Abutment Design Software For Dental Laboratory (Class II - Special Controls, product code PNP).
Submitted by Nobel Biocare AB (Goteborg, SE). The FDA issued a Cleared decision on March 1, 2019, 225 days after receiving the submission on July 19, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3630. The Device Is Intended To Aid In The Restoration Of Chewing Function By Allowing A Dental Laboratory Or Dental Clinician To Design The Patient-specific Component Of A Dental Abutment (i.e. Abutment Collar And Abutment Post) And Cam Or Create That Component At A Dental Office Or Dental Laboratory Following The Directions Of The Dental Implant System. The Abutment-to-implant Interface/connection Platform Is Not A Patient-specific Component Of The Dental Abutment..
| 510(k) Number | K181932 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 2018 |
| Decision Date | March 01, 2019 |
| Days to Decision | 225 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | PNP — Dental Abutment Design Software For Dental Laboratory |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3630 |
| Definition | The Device Is Intended To Aid In The Restoration Of Chewing Function By Allowing A Dental Laboratory Or Dental Clinician To Design The Patient-specific Component Of A Dental Abutment (i.e. Abutment Collar And Abutment Post) And Cam Or Create That Component At A Dental Office Or Dental Laboratory Following The Directions Of The Dental Implant System. The Abutment-to-implant Interface/connection Platform Is Not A Patient-specific Component Of The Dental Abutment. |