# K193274: Rodo Abutment System

- Pathway: 510(k) (Traditional)
- Applicant: Rodo Medical, Inc.
- Decided: Feb 27, 2020 after 93 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: 13 generations back to K894595 (1990). 152 ancestors in all.
No later device cites it as a predicate yet.
0 of 153 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160786: RODO Abutment System, Rodo Medical, Inc. (2016) Summary page 4.

## 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, 4.3, 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, 4.3, 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 Biohorizons Tapered Internal | 3.0, 3.5, 4.5, 5.7 | 3.0, 3.4, 3.8, 4.6, 5.8 Biomet 3i Certain Internal | 3.4, 4.1, 5.0, 6.0 | 3.25, 3.4, 4.1, 5.0, 6.0 Neodent GM | 3.5 | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0

Source page: https://510kreport.com/device/K193274
Methodology: https://510kreport.com/methodology