# K053654: Atlantis Abutment for Nobel Replace Interface

- Pathway: 510(k) (Traditional)
- Applicant: Atlantis Components, Inc.
- Decided: Jul 31, 2006 after 213 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: 4 generations back to K894595 (1990). 18 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981858: Atlantis Abutment and Atlantis Abutment Screw, Atlantis Components, Inc. (1999) Summary page 2.
- K023113: Replace Tiunite Endosseous Implant, Nobel Biocare Uas, Inc. (2002) Summary page 2.
- K020646: Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162, Nobel Biocare Uas, Inc. (2002) Summary page 2.

## Most influential descendants
- K110565: Abutments for Competitive Implant Systems-Nobel Replace (2011), 10 descendants of its own
- K112730: Abutment for Competitive Implant Straumann Bone Level Connection (2012), 9 descendants of its own
- K181037: DIO CAD/CAM Abutment (2018), 7 descendants of its own
- K222913: s-Clean Link Abutment (2023), 1 descendant of its own
- K210362: s-Clean Pre-Milled Abutment (2021), 1 descendant of its own

## Indications for use
The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. This device is compatible with the following manufacturers' implant systems: Nobel Biocare Replace Select Straight, Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage. Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

Source page: https://510kreport.com/device/K053654
Methodology: https://510kreport.com/methodology