# K120414: Osseospeed Plus - Pathway: 510(k) (Traditional) - Applicant: Astra Tech AB - Decided: Jul 31, 2012 after 172 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: 11 generations back to K894595 (1990). 149 ancestors in all. 196 later devices descend from it; 27 cite it directly. 0 of 346 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) - K101732: Astra Tech Implant System, Astra Tech AB (2011) - K091239: Astra Tech Implant System, Astra Tech AB (2009) Summary page 3. - K080396: Osseospeed Narrow, Astra Tech AB (2008) Summary page 3. - K120338: Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in Zirconia, Astra Tech, Inc. (2012). Cleared while this submission was under review Summary page 3. - K112138: Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant, Astra Tech, Inc. (2011) Summary page 3. - K111390: Sfi-Bar (R) Implant Adapter Spi (R) Element PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, Sfi-Bar (R) Implant Adapter Stra.., Cendres & Metaux SA (2011) - K110356: Atlantis Crown Abutment, Atlantis Gemini +(TM) Abutment, Astra Tech, Inc. (2011) Summary page 3. - K101849: Bicon Dental Implant System 3.0MM Bicon Dental Implant, Bicon, LLC (2010) Summary page 3. - K101005: Astra Tech Implant System, New Component, Astra Tech AB (2011) Summary page 3. - K083805: Ankylos C/X Dental Implant System, Dentsply Intl., Inc. (2009) Summary page 3. - K083496: Camlog Implant System Modified Implants and Abutments, Altatec GmbH (2009) Summary page 3. - K081666: Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0 Implants, Astra Tech, Inc. (2008) Summary page 3. - K072624: Astra Tech Implant System, New Component, Astra Tech AB (2007) Summary page 3. - K063286: Osseotite; Osseotite NT; XP; TG Osseotite, Implant Innovations, Inc. (2007) Summary page 3. - K980698: Astra Tech Implants - Dental System, Astra Tech, Inc. (1998) Summary page 3. - K974738: Astra Tech Implant Dental System, Astra Tech, Inc. (1998) Summary page 3. - K931767: Astra Tech Implants-Dental System, Astra Tech, Inc. (1994) Summary page 3. ## Most influential descendants - K170588: DESS Dental Smart Solutions (2017), 86 descendants of its own - K173908: DESS Dental Smart Solutions (2018), 51 descendants of its own - K150295: LOCATOR RTx (2015), 42 descendants of its own - K191986: DESS Dental Smart Solutions (2019), 38 descendants of its own - K182091: Osstem Abutment System (2019), 30 descendants of its own ## Indications for use Implants: The Astra Tech Dental Implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols: * replacing single and multiple missing teeth in the mandible and 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 loading in all indications, except in single tooth situations on implants shorter than 8 mm, or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate. The intended use for OsseoSpeedTM Plus 3.05 is limited to replacement of maxillary lateral incisors and mandibular incisors. Abutments: Astra Tech Implant System Plus abutments are intended to be used in conjunction with Astra Tech Implant System Plus in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures. Atlantis Abutments: The AtlantisTM 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 AtlantisTM Crown Abutment in Zirconia 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. Source page: https://510kreport.com/device/K120414 Methodology: https://510kreport.com/methodology