# K203344: Premilled Titanium Block System

- Pathway: 510(k) (Traditional)
- Applicant: Innobiosurg Co., Ltd.
- Decided: Aug 25, 2021 after 285 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: 15 generations back to K894844 (1990). 218 ancestors in all.
No later device cites it as a predicate yet.
0 of 219 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181037: DIO CAD/CAM Abutment, Dio Corporation (2018) Summary page 4.

## Indications for use
Premilled Titanium Block System is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Implant System Compatibility Implant Diameter (mm) Platform Diameter (mm) IBS Implant System I 3:8/4.3/4.8/5.3/5.8/6.3 3.8/4.3/4.8/5.3/5.8/6.3 IBS Implant System -iL 3.5/4.0/4.5/5.0/5.5/6.0/6.5 -L 3.5/4.0/4.5/5.0/5.5/6.0/6.5 Magicore System _ 4.0/4.5/5.0/5.5/6.0/6.5 4.0/4.5/5.0/5.5/6.0/6.5 :1 IBS Implant System II 1 3.5/3.8/4.0/4.5/5.0/5.5/6.0/6.5 1 3.5/3.8/4.0/4.5/5.0/5.5/6.0/6.5 -I] Premilled Titanium Block System is intended for use with the IBS implant system, Magicore System and IBS Implant System II in the chart. All digitally designed abutments for use with Premilled Titanium Block System are intended to be manufactured at a Innobiosurg validated milling center.

Source page: https://510kreport.com/device/K203344
Methodology: https://510kreport.com/methodology