# K162021: 3.0 Dynamic TiBase

- Pathway: 510(k) (Traditional)
- Applicant: Talladium Espana, SL
- Decided: May 4, 2018 after 652 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
3.0 Dynamic TiBase are intended for use with dental implants as a support for multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Compatibility of 3.0 Dynamic TiBase®: Implant Compatibility: DIO® — Trade Name IND3OTSHRP/TiA; Implant Diameter 4.0 mm; Abutment Post Height 4.0 mm; Multi-unit; Dynamic Screw; 0° to 30°; INTERNAL HEXAGON. OSSTEM® — Trade Name IND3OTSRNP/TiA; Implant Diameter 3.5 mm; Abutment Post Height 3.8 mm; Multi-unit; Dynamic Screw; 0° to 20°; INTERNAL HEXAGON. All Ti-base abutments, including the designed zirconia superstructure, are intended to be manufactured and finalized by Talladium Espana.

Source page: https://510kreport.com/device/K162021
Methodology: https://510kreport.com/methodology