# K070833: Atlantis Abutment for Astra Implant

- Pathway: 510(k) (Traditional)
- Applicant: Atlantis Components, Inc.
- Decided: Jun 22, 2007 after 87 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 K925765 (1993). 19 ancestors in all.
357 later devices descend from it; 4 cite it directly.
0 of 377 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062069: Atlantis Abutment for 3I Micromini Implant, Atlantis Components, Inc. (2007) Summary page 1.
- K053384: Fixature Microthread Osseospeed, a Component of the Astra Tech Implant System, Astra Tech, Inc. (2006) Summary page 1.
- K024111: Astra Tech Implants-Dental System Fixture Osseospeed, Astra Tech, Inc. (2003) Summary page 1.
- (no number) Astra Tech Implants-Dental System Fixture MicroMacro: named in the summary without a submission number

## Most influential descendants
- K081666: Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0 Implants (2008), 337 descendants of its own
- K100152: Sirona Cad/Cam System (2010), 240 descendants of its own
- K071946: Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra Implants (2007), 209 descendants of its own
- K110356: Atlantis Crown Abutment, Atlantis Gemini +(TM) Abutment (2011), 202 descendants of its own
- K112138: Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant (2011), 200 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. The Atlantis Abutment for Astra Implant is compatible with Astra's OsseoSpeedTM 3.5(S) mm, 4.0(S) mm Internal Hex Implants. 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/K070833
Methodology: https://510kreport.com/methodology