# K031719: Esthetic Zirconia Abutment

- Pathway: 510(k) (Special)
- Applicant: Nobel Biocare AB
- Decided: Jul 2, 2003 after 29 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- 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: 1 generation back to K913255 (1994). 1 ancestor in all.
514 later devices descend from it; 9 cite it directly.
0 of 516 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913255: Ceramic (TM) Abutment, Ceramic Core Corp. (1994) Summary page 1.

## Most influential descendants
- K042658: Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004 (2004), 441 descendants of its own
- K091756: Nobelprocera TI Abutment (2009), 278 descendants of its own
- K052070: Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis Gemeini + Abutment in Zirconia (2005), 261 descendants of its own
- K100152: Sirona Cad/Cam System (2010), 240 descendants of its own
- K093780: Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment, Atlantis Gemini + Abutment (2010), 200 descendants of its own

## Indications for use
Nobel Biocare's Esthetic Zirconia Abutment is indicated for the treatment of partially edentulous patients requiring prosthetic devices and/or endosseous implants to restore chewing function.

Source page: https://510kreport.com/device/K031719
Methodology: https://510kreport.com/methodology