# K032562: Proceara Copings and Pontic

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Feb 6, 2004 after 170 days
- Product code: ELL (Teeth, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.3920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910611 (1991). 3 ancestors in all.
29 later devices descend from it; 5 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910611: Nobelpharma Ceraone Abutment System, Nobelpharma USA, Inc. (1991) Summary page 1.
- K001418: Aluminum Oxide Powder, Sumicorundum AAO4S, Procera Sandvik, Inc. (2000) Summary page 1.
- K010630: Y-TZP Powder and Procera Allzirkon, Procera Sandvik, Inc. (2001)

## Most influential descendants
- K060530: SD Ceramic Coping for Quick Abutment, Locking. Model 45301.  RD Ceramic Coping for Quick Abutment, Locking, Model 45302. (2006), 15 descendants of its own
- K072241: Primaconnex Cad/Cam Abutment System (2007), 7 descendants of its own
- K062876: Primaconnex Ceramic Abutments (2006), 6 descendants of its own
- K041283: Procera Bridge Zirconia (2004), 5 descendants of its own
- K103020: Atlantis Abutment for Keystone Implant, Atlantis Gemini Abutment (2011), 4 descendants of its own

## Indications for use
Nobel Biocare's Procera Copings and Ponttic are indicated for use as core structures of an artificial prosthesis, i.e. a three-unit bridge, for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function. The Pontic is indicated as the core structure of the center unit and the Copings are indicated as the core structures of the two side crowns, thereby forming the three-unit bridge. The Copings are also indicated for use as single crowns that will be cemented to a natural or artificial tooth abutment in the treatment of partially edentulous patients in order to restore chewing function.

Source page: https://510kreport.com/device/K032562
Methodology: https://510kreport.com/methodology