# K121810: Osseospeed Angled Abutment EV

- Pathway: 510(k) (Traditional)
- Applicant: Astra Tech AB
- Decided: Jan 23, 2013 after 217 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: 11 generations back to K894595 (1990). 48 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111287: Astra Tech Implant System, Astra Tech AB (2011) Summary page 2.
- K112138: Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant, Astra Tech, Inc. (2011) Summary page 2.
- K110356: Atlantis Crown Abutment, Atlantis Gemini +(TM) Abutment, Astra Tech, Inc. (2011) Summary page 2.

## Most influential descendants
- K160207: ATLANTIS ISUS Implant Suprastructures (2016), 5 descendants of its own
- K163350: Multibase Abutments EV and ATLANTIS Suprastructures (2017), 4 descendants of its own
- K213449: DS Implants abutments provided with the EV connection (2021), 2 descendants of its own
- K130408: Era Micro 23  Female Abutment, Era Micro 30 Female Abutment (2013), 1 descendant of its own
- K220841: PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS) (2022), 0 descendants of its own

## Indications for use
OsseoSpeed Tm Angled Abutment BY is intended to be used in conjunction with Astra Tech Implant System BY in fully edentulous or partially edentulous maxillary and/ar mandibular arches to provide support for bridges or overdentures. The Atlantisgh Abutment is intended for use with 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 prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The Atlantisgh Crown Abutment in Zircania is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in -partially or completely edentulous patients. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant. Atlantism Abutment and AtlanI~ Crown Abutment are compatible with 05.4 Astra Tech Implant System By.

Source page: https://510kreport.com/device/K121810
Methodology: https://510kreport.com/methodology