# K972475: Auradapt Aubtment System

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare Uas, Inc.
- Decided: Sep 12, 1997 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: 3 generations back to K944964 (1995). 18 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934495: Branemark System (R) Ucla-Type Abutment Complete, Nobelpharma AB (1994) Summary page 1.
- K961737: Cera One Abutment System, Nobelpharma USA, Inc. (1996) Summary page 1.
- K925769: Branemark System Abutments Complete, Nobelpharma USA, Inc. (1993) Summary page 1.
- K953775: Brandemark Accessories to Ceramic Abutyment (Ceramicore), Nobelpharma USA, Inc. (1995) Summary page 1.
- K925766: Branemark System Temporary Solutions, Nobelpharma USA, Inc. (1994) Summary page 1.
- K962403: Noblepharma Wide Accessories, Nobelpharma USA, Inc. (1996) Summary page 1.
- K952448: 3.3MM Accessories, Nobelpharma USA, Inc. (1995) Summary page 1.
- K910611: Nobelpharma Ceraone Abutment System, Nobelpharma USA, Inc. (1991) Summary page 1.
- K922805: Nobelpharma Torque Controller, Nobelpharma USA, Inc. (1993) Summary page 1.
- K944963: Branemark System Smiline II, Nobelpharma USA, Inc. (1995) Summary page 1.
- (no number) CerAdapt™: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K911969: Guide Pin. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.
- K926766: Temporary Tube. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K083100: Goldadapt Non-Engaging Nobelactive NP & RP, Goldadapt Engaging Nobelactive NP & RP (2008), 1 descendant of its own
- K112259: Nobelactive 3.0 Goldadapt Abutments (2011), 0 descendants of its own

## Indications for use
Nobel Biocare’s AurAdapt Abutment System is a set of screw retained modifiable gold alloy 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/K972475
Methodology: https://510kreport.com/methodology