# K151439: Atlantis Isus

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply International, Inc.
- Decided: Feb 19, 2016 after 266 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: 9 generations back to K944964 (1995). 89 ancestors in all.
No later device cites it as a predicate yet.
0 of 90 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 4.
- K090069: Procera Implant Bridge Overdenture, Nobel Biocare AB (2009) Summary page 4.
- K131644: Ankylos Syncone Abutment 5(Degree), Dentsply International, Inc. (2014) Summary page 4.
- K133377: Nobelprocera Angulated Screw Channel Abutment Replace, Nobel Biocare AB (2014) Summary page 4.

## 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: 3i Internal Connection: D3.4, D4.1, D5, D6 Friadent XiVE S: D3.0, D3.4, D3.8, D4.5, D5.5 Nobel Biocare Active Internal: NP (3.5mm), RP (4.3mm, 5.0mm) Nobel Biocare Replace Select: NP (3.5mm), RP (4.3mm), WP (5.0mm) and Replace Select 6.0mm Straumann Bone Level: NC (3.3mm), RC (4.lmm, 4.8mm) Straumann NN (3.5mm), RN (4.8mm), WN (6.0mm) Zimmer Screw Vent: D3.5, D4.5, D5.7 Abutments: 3i Low Profile Abutment ANKYLOS Balance Base Abutment D5.5 and Narrow Abutment D4.2 ASTRA TECH 20° and 45° UniAbutment Astra Tech UniAbutment EV 3.6 Friadent XiVE MP D3.8, D4.5, D5.5 Friadent XiVE TG D3.8,D 4.5, D5.5 Nobel Biocare Multi-Unit Abutment RP: 4.0 mm Straumann Bone Level Angled Abutment: 4.0 mm Straumann Bone Level: Multi-Base Abutment D3.5, D4.5 Straumann RN (4.8 mm), WN (6.5 mm) Zimmer Tapered Abutment: 4.5 mm

Source page: https://510kreport.com/device/K151439
Methodology: https://510kreport.com/methodology