# K163350: Multibase Abutments EV and ATLANTIS Suprastructures

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Mar 31, 2017 after 121 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: 14 generations back to K894595 (1990). 236 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 241 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121810: Osseospeed Angled Abutment EV, Astra Tech AB (2013) Summary page 6.
- K072570: Nobelactive Multi Unit Abutment, Nobel Biocare AB (2007) Summary page 6.
- K120414: Osseospeed Plus, Astra Tech AB (2012) Summary page 6.
- K130999: Osseospeed Profile EV, Dentsply Implants Manufacturing GmbH (2013) Summary page 6.
- K160207: ATLANTIS ISUS Implant Suprastructures, Dentsply International, Inc. (2016) Summary page 6.

## Most influential descendants
- 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
The Multibase Abutments EV are intended to be used in conjunction with Astra Tech Implant System EV in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for bridges or overdentures. ATLANTIS™ 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™ 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/ Tapered S-V 3.5/S-V 3.3, 3.7 Screw Vent /Tapered S-V 4.5/ S-V 4.5 Tapered Screw Vent 5.7 Abutments: Manufacturer Name of Abutment Biomet 3i Low Profile Abutment DENTSPLY 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 ATIS Multibase Abutment EV 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 Abutment

Source page: https://510kreport.com/device/K163350
Methodology: https://510kreport.com/methodology