# K061477: Multi-Unit Abutments for Astratech, Camlog and Ankylos Implant Systems

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Aug 11, 2006 after 73 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 K894595 (1990). 20 ancestors in all.
66 later devices descend from it; 6 cite it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925769: Branemark System Abutments Complete, Nobelpharma USA, Inc. (1993) 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.
- K041509: Ankylos Dental Implant System, Friadent GmbH (2004) Summary page 1.

## Most influential descendants
- K093643: Multi- Unit Abutments for Straumann and Astra Tech Implant Systems (2010), 34 descendants of its own
- K103252: Camlog Vario SR Abutments (2011), 32 descendants of its own
- K132125: A.B. Dental Devices Dental Implants System (2014), 25 descendants of its own
- K121334: Varioeco (2012), 16 descendants of its own
- K160244: VARIOunite (2016), 15 descendants of its own

## Indications for use
Nobel Biocare's Multi-Unit Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. Nobel Biocare's Multi-Unit 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 - Ankylos 3.5, 4.5, 5.5, 7.0 mm

Source page: https://510kreport.com/device/K061477
Methodology: https://510kreport.com/methodology