# K231932: TDS (Techwin Dental System)

- Pathway: 510(k) (Traditional)
- Applicant: Techwin Co., Ltd.
- Decided: Aug 20, 2024 after 417 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: 11 generations back to K894595 (1990). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160536: Chaorum Implant System, Medimecca Co., Ltd. (2017) Summary page 4.

## Indications for use
The TDS (TECHWIN DENTAL SYSTEM) are prefabricated prosthetic components for direct connection to endosseous dental implants and are intended to be used as an aid in prosthetic rehabilitation. It is intended for use in edentulous and partially edentulous patients with established bone and completed growth period to support single unit prosthetic restorations in the mandible or maxilla. It is intended for one-stage and two-stage surgical procedures. This system is intended for delayed loading. The TDS (TECHWIN DENTAL SYSTEM) is compatible with the following devices: No. Subject Implantable Compatible Type of Implant Implant Implant Platform Implant Body Device Diameters (mm) Implants (510k Abutment Platform Platform Diameter No.)/Manufacture Connection/ Type Diameters(mm) (mm) 1. Dual 4.0, 4.6 Chaorum Hex or non-hex/ Narrow ©3.25, 3.89 3.0, 3.5 Abutment Implant System 2.1 Hex (mini) (K160536)/ 04.5,4.6,5.0,5.5, MEDIMECCA Hex or non-hex/ Wide (3.89, 4.28, 23.9,4.0, 4.4, 6.0,6.5,7.0 CO., LTD. 2.5 Hex (Regular) 4.78,5.28,6.28 4.5,4.9,5.5,5.9 2. Healing 4.3,4.8 Hex or non-hex/ Narrow ©3.25, 3.89 3.0, 3.5 Abutment 2.1 Hex (mini) 04.0,4.3,4.5, 4.6, Hex or non-hex/ Wide 03.89, 4.28, 03.9,4.0,4.4, 4.8,53,5.5,5.6,6.3. 2.5 Hex (Regular) 4.78,5.28,6.28 4.5,4.9,5.5,5.9 6.5,7.3,75,8.3,85 3. Abutment 02.22 - Narrow - - Screw (mini) 02.1,2.3,2.32,2.5 - Wide - - (Regular)

Source page: https://510kreport.com/device/K231932
Methodology: https://510kreport.com/methodology