# K062197: Atlantis Abutment for 3I Certain Micro Mini; Gemini and Gemini+ Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Atlantis Components, Inc.
- Decided: Feb 28, 2007 after 211 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 K925765 (1993). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 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.
- K051011: Endosseous Dental Implant Abutment, Atlantis Components, Inc. (2005) Summary page 1.
- K014235: Osseotite NT Dental Implants & Accessories, Implant Innovations, Inc. (2002) Summary page 1.

## 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 31 Certain MicroMini Implant is compatible with 31 Osseotite: NT® Certain and Parallel Walled Implants both with 3.25 mm diameters. 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. Hlighly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended tbr the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant fixture.

Source page: https://510kreport.com/device/K062197
Methodology: https://510kreport.com/methodology