# K200100: Abutment Design

- Pathway: 510(k) (Traditional)
- Applicant: 3Shape A/S
- Decided: Oct 7, 2020 after 265 days
- Product code: PNP (Dental Abutment Design Software For Dental Laboratory)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K894844 (1990). 117 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151455: 3Shape Abutment Designer Software, 3Shape A/S (2016) Summary page 4.

## Most influential descendants
- K233252: Straumann CARES Visual and Nova Dental CAD (2024), 0 descendants of its own
- K231529: CloudPoint FastDesign Chairside (2024), 0 descendants of its own
- K221107: TRUST (2023), 0 descendants of its own

## Indications for use
Abutment Design is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. Abutment Design is intended for use by a dental practitioner or dental laboratory staff for designing the patient specific component of a two-piece, one-piece, or hybrid dental implant abutment. The resulting abutment design is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

Source page: https://510kreport.com/device/K200100
Methodology: https://510kreport.com/methodology