# K061478: Procera Titanium Abutment for Astratech and Camlog Implant Systems

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Aug 21, 2006 after 83 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: 7 generations back to K944964 (1995). 49 ancestors in all.
33 later devices descend from it; 1 cites it directly.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041275: Procera Abutment Octagon, Nobel Biocare Uas, Inc. (2004) Summary page 1.
- 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.
- K053384: Fixature Microthread Osseospeed, a Component of the Astra Tech Implant System, Astra Tech, Inc. (2006) Summary page 1.
- K022425: Screwline, Altatec Biotechnologies N.A., Inc. (2002) Summary page 1.

## Most influential descendants
- K103252: Camlog Vario SR Abutments (2011), 32 descendants of its own
- K121334: Varioeco (2012), 16 descendants of its own
- K160244: VARIOunite (2016), 15 descendants of its own
- K113779: Conelog Implant System (2012), 14 descendants of its own
- K163634: External Hex Implants (2017), 13 descendants of its own

## Indications for use
Nobel Biocare's Procera Titanium Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. Nobel Biocare's Procera Titanium Abutments fit the following endosseous implants: - AstraTech 3.5, 4.0, 4.5, 5.0 mm - Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm

Source page: https://510kreport.com/device/K061478
Methodology: https://510kreport.com/methodology
