# K243530: Dynamic TiBase

- Pathway: 510(k) (Traditional)
- Applicant: Talladium España, SL
- Decided: May 30, 2025 after 197 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: 22 generations back to K960026 (1996). 326 ancestors in all.
No later device cites it as a predicate yet.
0 of 327 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232151: Dynamic TiBase, Talladium España, SL (2023) Summary page 5.

## Indications for use
Dynamic TiBase abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. Compatible Implant Systems Compatible Implant System (Connection) | Implant Body Diameter, mm | Implant Platform, mm Osstem® TS | 3.5 | Mini Hiossen® ET (Internal Taper) | 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 | Regular Neodent GM (Morse taper) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | GM Straumann Bone Level (CrossFit® Morse Taper) | 3.3 | NC Straumann Bone Level (CrossFit® Morse Taper) | 4.1, 4.8 | RC Straumann BLX (TorcFit™ Internal Hexalobular) | 3.5, 3.75, 4.0, 4.5 | RB Straumann BLX (TorcFit™ Internal Hexalobular) | 5.0, 5.5, 6.5 | WB Compatible Abutment System Compatible Abutment System (Connection) | Compatible Abutment Angulation | Compatible Abutment Platforms Nobel Biocare Multi-Unit Abutment Plus (Conical Connection) | 0° only | NP, RP, WP All digitally designed custom abutments for use with Dynamic TiBase abutments are to be sent to a Talladium Medical validated milling center for manufacture.

Source page: https://510kreport.com/device/K243530
Methodology: https://510kreport.com/methodology