# K974150: Procera Preparable Abutment System

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare Uas, Inc.
- Decided: Jan 23, 1998 after 80 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K944964 (1995). 19 ancestors in all.
543 later devices descend from it; 5 cite it directly.
0 of 563 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971706: Tiadapt Abutment System, Nobel Biocare Uas, Inc. (1997) Summary page 1.

## Most influential descendants
- K032263: 3I Patient-Specific Dental Abutment and Overdenture Bar (2004), 476 descendants of its own
- K042658: Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004 (2004), 441 descendants of its own
- K043042: Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 (2004), 327 descendants of its own
- K090069: Procera Implant Bridge Overdenture (2009), 313 descendants of its own
- K091756: Nobelprocera TI Abutment (2009), 278 descendants of its own

## Recalls of this device
- Aug 9, 2019 · Class II · Z-1853-2020: Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened
- Aug 9, 2019 · Class II · Z-1852-2020: Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened

## Indications for use
Nobel Biocare’s Procera Abutment System is a set of screw retained preparable abutments which are secured to an endosseous implant and is intended to function as an anchor to which prosthetic devices, such as artificial teeth, may be attached using dental cement to restore a patient’s chewing function.

Source page: https://510kreport.com/device/K974150
Methodology: https://510kreport.com/methodology