# K130999: Osseospeed Profile EV - Pathway: 510(k) (Traditional) - Applicant: Dentsply Implants Manufacturing GmbH - Decided: Oct 25, 2013 after 198 days - Product code: DZE (Implant, Endosseous, Root-Form) - Device class: 2 - Regulation: 21 CFR 872.3640 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 12 generations back to K894595 (1990). 153 ancestors in all. 18 later devices descend from it; 4 cite it directly. 0 of 172 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K120414: Osseospeed Plus, Astra Tech AB (2012) Summary page 3. - K080156: Osseospeed TM Profile System, Astra Tech AB (2008) Summary page 3. - K103759: Atlantis Abutment in Zirconia for Osseospeed TX Profile Implant, Astra Tech, Inc. (2011) Summary page 3. - K112138: Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant, Astra Tech, Inc. (2011) Summary page 3. - K072624: Astra Tech Implant System, New Component, Astra Tech AB (2007) Summary page 3. - K101732: Astra Tech Implant System, Astra Tech AB (2011) Summary page 3. - K051652: Atlantis Abutment, Atlantis Gemini Abutment, Atlantis Gemini+ Abutment, Atlantis Components, Inc. (2005) Summary page 3. - K041509: Ankylos Dental Implant System, Friadent GmbH (2004) Summary page 3. ## Most influential descendants - K160626: ATLANTIS Abutment for HIOSSEN ET implant (2016), 9 descendants of its own - K172225: Atlantis Abutment for MIS Implant (2017), 8 descendants of its own - K160207: ATLANTIS ISUS Implant Suprastructures (2016), 5 descendants of its own - K163350: Multibase Abutments EV and ATLANTIS Suprastructures (2017), 4 descendants of its own - K203660: TRI-matrix Implant Line (2021), 3 descendants of its own ## Indications for use Implants: The ASTRA TECH Implant System - OsseoSpeed Profile EV implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols: * replacing missing teeth in single or multiple unit applications in the mandible or maxilla. * immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge * especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective * immediate and early loading for all indications * together with immediate loading protocol in all indications, except in single tooth situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate * only together with Profile EV components, Implant Driver Profile EV, Radiographic Implant Guides Profile EV and non-Indexed prosthetic components Abutments: ASTRA TECH Implant System - OsseoSpeed EV abutments are intended to be used in conjunction with ASTRA TECH Implant System - OsseoSpeed EV in fully edentulous or partially edentulous maxillary and/or mandibular arches. The ATLANTIS 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 ATLANTIS Crown Abutment 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. The ATLANTIS Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment-retained by friction fit to the abutment. The abutment screw is intended to secure the ATLANTIS Abutment to the endosseous implant. ATLANTIS Abutment, ATLANTIS Crown Abutment and ATLANTIS Conus Abutment are compatible with ASTRA TECH Implant System Profile EV. Source page: https://510kreport.com/device/K130999 Methodology: https://510kreport.com/methodology