# K062277: Atlantis Abutment in Zirconia for Nobel Biocare Replace

- Pathway: 510(k) (Traditional)
- Applicant: Atlantis Components, Inc.
- Decided: Dec 20, 2006 after 135 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: 8 generations back to K944964 (1995). 50 ancestors in all.
71 later devices descend from it; 5 cite it directly.
0 of 122 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 1.
- K023113: Replace Tiunite Endosseous Implant, Nobel Biocare Uas, Inc. (2002) Summary page 1.
- K052070: Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis Gemeini + Abutment in Zirconia, Atlantis Components, Inc. (2005) Summary page 1.

## Most influential descendants
- K091920: Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel Replace Implants, Atlantis Gemini + Abutment for Nobel (2009), 40 descendants of its own
- K103291: Biohorizons Laser-Lok Abutments for Nobel Biocare (2011), 30 descendants of its own
- K122295: Core 3D Abutment System for Digital Prosthetic Solutions (2013), 29 descendants of its own
- K083480: Inclusive Zirconia Abutment Blanks (2009), 27 descendants of its own
- K151621: BioHorizons CAD/CAM Abutments (2016), 26 descendants 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, Zimmer Dental, 3i, Lifecore, Stemgold, Innova and BioHorizons. 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. Also, highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 nun 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/K062277
Methodology: https://510kreport.com/methodology