K200100 is an FDA 510(k) clearance for the Abutment Design. This device is classified as a Dental Abutment Design Software For Dental Laboratory (Class II - Special Controls, product code PNP).
Submitted by 3Shape A/S (Copenhagen, DK). The FDA issued a Cleared decision on October 7, 2020, 265 days after receiving the submission on January 16, 2020.
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 | K200100 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 2020 |
| Decision Date | October 07, 2020 |
| Days to Decision | 265 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. |