# K193064: Atlantis suprastructures

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona, Inc.
- Decided: Mar 3, 2020 after 120 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: 15 generations back to K894595 (1990). 238 ancestors in all.
No later device cites it as a predicate yet.
0 of 239 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163350: Multibase Abutments EV and ATLANTIS Suprastructures, Dentsply Sirona (2017) Summary page 6.
- K163398: ATLANTIS suprastructures, Dentsply Sirona (2017) Summary page 6.

## Indications for use
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. Atlantis® suprastructures are compatible with following implants and abutments: Manufacturer/ Implant system C BioHorizons Implant Level Internal/ Tapered 3.5, 4.5, 5.7 Abutment Level Multi-unit abutment Biomet 3i Implant Level Certain™ 3.25, 4.0, 4/3, 5.0, 5/4, 6.0 Certain™ Prevail™ 3/4/3 (3.4), 4/5/4, 5/6/5, 4/3, 5/4, 6/5 Certain™ XP 4/5, 5/6 Abutment Level Low Profile Abutment Camlog Implant Level Screw-line Implant 3.3 Screw-line/Root-line Implant 3.8, 4.3 Screw-line/Root-line Implant 5.0, 6.0 Dentsply Implant Level Sirona Astra Tech Implant System® Astra Tech Implant EV 3.0 – Green Astra Tech Implant EV 3.6 – Purple Astra Tech Implant EV 4.2 – Yellow Astra Tech Implant EV 4.8 – Blue Astra Tech Implant EV 5.4 – Brown Astra Tech Implant EV Profile 4.2 Astra Tech Implant EV Profile 4.8 OsseoSpeed® TX 3.0 – Yellow OsseoSpeed® TX 3.5, 4.0 – Aqua OsseoSpeed® TX 4.5, 5.0 – Lilac OsseoSpeed® TX Profile 4.5/5.0 Xive® Xive® S 3.0 Xive® S 3.4, 3.8, 4.5, 5.5 Abutment Level Astra Tech Implant System® UniAbutment EV Angled Abutment EV Multibase Abutment EV 20° UniAbutment 45° UniAbutment Angled Abutment 20° Ankylos® Ankylos® Balance Base Narrow D4.2 Ankylos® Balance Base D5.5 Xive® Xive® TG 3.4, 3.8, 4.5 Xive® MP 3.4, 3.8, 4.5 Xive® MP 5.5 Keystone Implant Level 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 MIS Implant Level Internal Hex Narrow SEVEN – M4 Internal Hex Standard SEVEN – M4 Internal Hex Wide SEVEN – M4 Conical Connection Narrow C1 – V3 Conical Connection Standard C1 – V3 Conical Connection Wide C1 Abutment Level Multi-Unit Abutment Nobel Biocare Implant Level NobelActive NP 3.5 NobelActive RP 4.3, 5.0 NobelActive WP 5.5 NobelReplace NP 3.5 NobelReplace RP 4.3 NobelReplace WP 5.0 NobelReplace 6.0 Branemark System NP 3.3 Branemark System RP 3.75, 4.0 Abutment Level Multi-Unit Abutment RP Straumann Implant Level Bone Level 3.3 NC Bone Level 4.1, 4.8 RC Standard/Standard Plus 4.8 RN (Regular Neck) Standard/Standard Plus 4.8 WN (Wide Neck) Abutment Level RN Abutment Level WN Abutment Level Bone Level Multi-Base Abutment D3.5, 4.5 Bone Level Multi-Base Angled Abutment Screw-Retained Abutment 3.5 Screw-Retained Abutment 4.6 Zimmer Dental Implant Level Tapered Screw-Vent™ 3.5, 4.5, 5.7 Screw Vent™ 3.3, 3.7, 4.5 Abutment Level Tapered Abutment

Source page: https://510kreport.com/device/K193064
Methodology: https://510kreport.com/methodology