# K242978: Geo Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Geomedi Co,., Ltd.
- Decided: Jun 16, 2025 after 263 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: 17 generations back to K960026 (1996). 318 ancestors in all.
No later device cites it as a predicate yet.
0 of 319 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182246: Mist IC, Imagine Milling Technologies, LLC (2019) Summary page 5.

## Indications for use
Geo Abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single-unit or multi-unit cement-retained prosthesis in the mandible or maxilla. Geo Abutments are compatible with the following implants. Compatible Implant Systems Compatible Implant Systems | GeoMedi Code for OEM | Implant Body Diameter, mm | Implant/Abutment Connection Dentium Superline | DER | 3.6, 4.0, 4.5, 5.0, 5.8 | Universal DIO UF II | SURD | 3.8, 4.0, 4.5, 5.0, 5.5, 5.9, 6.4, 6.9 | Universal Hiossen ETIII SA Mini | SUM | 3.75, 3.77 | TS Mini Hiossen ETIII SA | SURO | 4.25, 4.65, 4.63, 4.6, 5.1, 5.08, 5.05 | TS Regular Hiossen ETIII SA Ultra-Wide | SURO | 5.9, 5.92, 5.95, 6.0, 6.8, 6.82 | TS Regular Megagen AnyOne Internal (normal thread, deep thread, special length) | DERA (MAO) | 3.9, 4.3, 4.8, 5.3, 5.8, 6.3, 6.8, 7.3, 7.8, 8.3 | Universal Megagen AnyRidge Internal (normal ridge, deep ridge) | MARR | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9, 7.4, 7.9, 8.4 | Universal Megagen MiNi Internal | MMN | 3.0, 3.4 | MINI All digitally designed custom abutments for use with Geo Abutments are to be sent to a GeoMedi Co. Ltd. validated milling center for manufacture.

Source page: https://510kreport.com/device/K242978
Methodology: https://510kreport.com/methodology