# K061971: Zirconia Implant

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Mar 6, 2007 after 237 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- 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 K022562 (2002). 2 ancestors in all.
30 later devices descend from it; 4 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)
- K023952: Replace One Piece Implant, HA, Replace One Piece Implant, Tiunite, Nobel Biocare Uas, Inc. (2003) Summary page 1.
- K022562: Various Branemark System Implants-Immediate Function Indication, Nobel Biocare AB (2002) Summary page 1.

## Most influential descendants
- K093595: Ceraroot Implant System (2011), 27 descendants of its own
- K120793: Z-LOOK3 Evo SLM (2012), 19 descendants of its own
- K151328: PURE Ceramic Implants (2016), 12 descendants of its own
- K171769: Straumann PURE Ceramic Implants (2017), 8 descendants of its own
- K132881: Z5C (2014), 8 descendants of its own

## Indications for use
Nobel Biocare's Zirconia Implants are root-form endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Zirconia Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare Zirconia Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manual are satisfied.

Source page: https://510kreport.com/device/K061971
Methodology: https://510kreport.com/methodology