# K201700: BEGO Semados® RS/RSX Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Bego Implant Systems GmbH & Co. KG
- Decided: Jan 13, 2021 after 205 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K894595 (1990). 95 ancestors in all.
No later device cites it as a predicate yet.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142260: NobelActive, Nobel Biocare AB (2015) Summary page 5.
- K090716: Bego Semados S-Line, Bego Implant Systems GmbH & Co. KG (2009) Summary page 5.

## Indications for use
The BEGO Semados@ RS/RSX Implant System consists of implants, healing posts and abutments. The BEGO Semados@ RS/RSX implant is indicated for single or multiple unit restorations on splinted or non-splinted applications both in the upper and lower jaw. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading, depending on sufficient primary stability and appropriate occlusal loading. The BEGO Semados@ RS/RSX implant 3.0 is only indicated for single unit restorations of the lower lateral, central incisors or upper lateral incisors. The healing posts are indicated for patients treated with BEGO Semados@ RS/RSX implants for the time during healing of the surrounding soft tissue. The abutments are indicated for patients treated with BEGO Semados@ RS/RSX implants as an aid in prosthetic rehabilitation. PS ITA, PS TTiA and PS TTiA NH are intended to be used for a maximum period of 6 months.

Source page: https://510kreport.com/device/K201700
Methodology: https://510kreport.com/methodology