# K091904: Nobelprocera ZI Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Sep 25, 2009 after 92 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: 8 generations back to K944964 (1995). 63 ancestors in all.
35 later devices descend from it; 2 cite it directly.
0 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042658: Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004, Nobel Biocare Uas, Inc. (2004) Summary page 1.
- K090069: Procera Implant Bridge Overdenture, Nobel Biocare AB (2009). Our OCR of the scanned summary read K090064, FDA’s number for Eminent Spine Interbody Fusion System (Eminent Spine). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Nobel Biocare — Procera® Implant Bridge Overdenture”.

## Most influential descendants
- K132125: A.B. Dental Devices Dental Implants System (2014), 25 descendants of its own
- K140440: Noris Medical Dental Implants System (2014), 14 descendants of its own
- K132881: Z5C (2014), 8 descendants of its own
- K151909: Noris Medical Zygomatic Dental Implant System (2016), 7 descendants of its own
- K172668: W Zirconia Implants (2018), 4 descendants of its own

## Indications for use
The NobelProcera Zi Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

Source page: https://510kreport.com/device/K091904
Methodology: https://510kreport.com/methodology