# K160786: RODO Abutment System

- Pathway: 510(k) (Traditional)
- Applicant: Rodo Medical, Inc.
- Decided: Nov 21, 2016 after 244 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: 12 generations back to K894595 (1990). 151 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 154 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120414: Osseospeed Plus, Astra Tech AB (2012) Summary page 4.
- K092341: Low Profile Abutments - Internal and External Connection, Biomet 3i, Inc. (2009) Summary page 4.

## Most influential descendants
- K193274: Rodo Abutment System (2020), 0 descendants of its own
- K180609: Rodo Smilekey (2018), 0 descendants of its own

## Indications for use
Rodo Abutment System is intended to be used in conjunction with compatible implant systems in the maxillary or mandibular arch to provide support for crowns, bridges or overdentures. Compatible Systems Implant Line OEM Platform Size OEM Body Size Straumann Bone Level NC, RC 3.3,4.1,4.8 Neodent Drive CM 3.5,4.3,5.0 3.5,4.3,5.0 Neodent Titamax CM 3.5,3.75,4.0,5.0 3.5,3.75,4.0,5.0 Neodent Alvim CM 3.5,43,5.0 3.5,4.3,5.0 NobelActive 3.0, NP, RP, WP 3.0,3.5,4.3,5.0,5.5 Nobel Replace Conical NP, RP 3.5,43,5.0 NobelReplace Straight NP, RP, WP 3.5,4.0,5.0 NobelReplace Tapered NP, RP, WP, 6.0 3.5,4.3,5.0,6.0 NobelSpeedy Replace NP, RP, WP, 6.0 3.5,4.0,5.0,6.0

Source page: https://510kreport.com/device/K160786
Methodology: https://510kreport.com/methodology