# K160207: ATLANTIS ISUS Implant Suprastructures - Pathway: 510(k) (Traditional) - Applicant: Dentsply International, Inc. - Decided: Sep 21, 2016 after 237 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: 13 generations back to K894595 (1990). 233 ancestors in all. 5 later devices descend from it; 1 cites it directly. 0 of 239 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K122424: Isus Implant Suprastructures, Dentsply International, Inc. (2013) Summary page 5. - K121810: Osseospeed Angled Abutment EV, Astra Tech AB (2013) Summary page 5. - K931767: Astra Tech Implants-Dental System, Astra Tech, Inc. (1994) Summary page 5. - K101732: Astra Tech Implant System, Astra Tech AB (2011) Summary page 5. - K120414: Osseospeed Plus, Astra Tech AB (2012) Summary page 5. - K080156: Osseospeed TM Profile System, Astra Tech AB (2008) Summary page 5. - K130999: Osseospeed Profile EV, Dentsply Implants Manufacturing GmbH (2013) Summary page 5. - K071638: Biohorizons Tapered Internal Implant System, BioHorizons Implant Systems, Inc. (2007) Summary page 5. - K000099: Camlog Screw Implant System, Altatec Biotechnologies (2000) Summary page 5. - K000100: Camlog Rootform Implant System, Altatec Biotechnologies (2000) Summary page 6. - K051614: Primaconnex Internal Connection Implant System, Primaconnex Internal Connection Prosthetics, Lifecore Biomedical, Inc. (2005) Summary page 6. - K101545: Genesis Implant System, Keystone Dental (2010) Summary page 6. - K133421: Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal Screw, Straumann USA, LLC (2014) Summary page 6. ## Most influential descendants - 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 - K220841: PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS) (2022), 0 descendants of its own - K221094: OmniTaper EV Dental Implants, DS Implants abutments with EV connection (2022), 0 descendants of its own - K193064: Atlantis suprastructures (2020), 0 descendants of its own ## Indications for use ATLANTIS™ ISUS Implant Suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. ATLANTIS™ ISUS Implant Suprastructures are intended for attachment to a minimum of two (2) implants and are indicated for compatibility with the following implant and abutment systems: Implants: Manufacturer Name of Implant Size Biomet 3i Certain 3.25, 4/3 – Prevail 3/4/3, 4/3 Certain 4.0, 5/4 – Prevail 4/5/4. 5/4 Certain 5.0, XP 4/5 – Prevail 5/6/5, 6/5 Certain 6.0, XP 5/6 BioHorizons Internal/Tapered 3.5, 4.5, 5.7 Camlog Screw-line Implant 3.3 Screw-line / Root-line Implant 3.8, 4.3, 5.0, 6.0 DENTSPLY Implants XiVE S 3.0, S 3.4, S 3.8, S 4.5, S 5.5 OsseoSpeed™ TX 3.0, 3.5/4.0, 4.5/5.0 Osseospeed™ Profile TX 4.5/5.0 Osseospeed™ EV 3.0, 3.6, 4.2, 4.8, 5.4 Osseospeed™ Profile EV 4.2, 4.8 Keystone Dental PrimaConnex SD 3.3/3.5 PrimaConnex RD 4.0/4.1 PrimaConnex WD 5.0 Genesis 3.8, 4.5, 5.5/6.5 Nobel Biocare NobelActive NP 3.5 – RP 4.3, 5.0 NobelReplace NP-3.5 – RP 4.3 – WP 5.0 – 6.0 Straumann Bone Level 3.3 NC – 4.1, 4.8 NC Standard Plus 3.5 NN Standard / Standard Plus 4.8 RN – 4.8 WN Zimmer Dental Tapered Screw Vent S-V 3.5/S-V 3.3, 3.7 / S-V 4.5/ S-V 4.5 Tapered Screw Vent 5.7 Abutments: Manufacturer Name of Abutment Biomet 3i Low Profile Abutment DENTSPLY Implants ATIS Uni Abutment EV ATIS UniAbutment 20°, ATIS UniAbutment 45° ATIS Angled Abutment EV ATIS Angled Abutment 20° ANKYLOS Balance Base Narrow D4.2, Balance Base D5.5 XiVE MP 3.4, MP 3.8, MP 4.5, MP 5.5 XiVE TG 3.4, TG 3.8, TG 4.5 Nobel Biocare Multi-Unit Abutment RP Straumann Bone Level Multi-Base Angled Abutment Bone Level Multi-Base Abutment D3.5, D4.5 RN Abutment Level, WN Abutment Level Screw-Retained Abutment 3.5, 4.6 Zimmer Dental Tapered Abument Source page: https://510kreport.com/device/K160207 Methodology: https://510kreport.com/methodology