# K122424: Isus Implant Suprastructures

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply International, Inc.
- Decided: Jul 5, 2013 after 330 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: 8 generations back to K944964 (1995). 63 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101582: Cam Structsure Bars, Biomet 3i, Inc. (2010) Summary page 1.
- K090069: Procera Implant Bridge Overdenture, Nobel Biocare AB (2009) Summary page 1.
- K013438: Frialit-2 Estheticbase Abutment, Friadent GmbH (2001) Summary page 1.

## Most influential descendants
- K160207: ATLANTIS ISUS Implant Suprastructures (2016), 5 descendants of its own
- K212676: Osteon Precision Milled Suprastructure (2022), 4 descendants of its own
- K163350: Multibase Abutments EV and ATLANTIS Suprastructures (2017), 4 descendants of its own
- K221019: Osteon Precision Milled Suprastructure (2022), 3 descendants of its own
- K233083: Osteon Precision Milled Suprastructure (2024), 2 descendants of its own

## Indications for use
The 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. The ISUS Implant Suprastructures are intended for attachment to a minimum of two (2) implants. ISUS Implant Suprastructures are indicated for compatibility with the following implant and abutment systems: Implants: * Nobel Biocare Replace Select: NP (3.5mm), RP (4.3mm), WP (5.0mm), and Replace Select 6.0mm * Nobel Biocare Active Internal: NP (3.5mm), RP (4.3mm, 5.0mm) * Zimmer Screw Vent: 1D3.5, D4.5, D5.7 * Straumann: NN (3.5mm), RN (4.8mm), WN (6.0mm) * Straumann Bone Level: NC (3.3mm), RC (4.1 mm, 4.8mm) * 3i Internal Connection: D3.4, D4.1, D5, D6 * Friadent XiVE S: D3, D3.4, D3.8, D4.5, D5.5 Abutments: * ASTRA TECH- 200 and 450 UniAbutment * ASTRA TECH UniAbutment EV: 3.6 * ANKYLOS Balance Base Abutment D5.5 and Narrow Abutment D4.2 * Nobel Biocare Multi-Unit Abutment RP: 4.0 mm * Zimmer Tapered Abutment: 4.5mm * Straumann RN(4.8mm), WN (6.5 mm) * Straumann Bone Level: Multi-Base Abutment D3.5, D4.5 * Straumann Bone Level Angled Abutment: 4.0 mm * 3i Low Profile Abutment * Friadent XiVE MP D3.8, D4.5, D5.5 * Friadent XiVE TG D3.8, D4.5, D5.5

Source page: https://510kreport.com/device/K122424
Methodology: https://510kreport.com/methodology