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510(k) Data Aggregation
K Number
K231932Device Name
TDS (TECHWIN DENTAL SYSTEM)
Manufacturer
Techwin Co., Ltd.
Date Cleared
2024-08-20
(417 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
Techwin Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
The TDS (TECHWIN DENTAL SYSTEM), made of Ti-6A1-4V ELI alloy (ASTM F136), is intended for use in conjunction with the appliance in partially or fully edentulous mandibles and maxillae to support single-unit loading (i.e., crown). It consists of the Dual Abutment and Healing Abutment. The surface of the abutments is uncoated or partially or half coated with TiN using AIP (Arc Ion Plating). The implant-to-abutment interface remains uncoated. All abutments are supplied non-sterile and must be autoclaved by the end-user.
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K Number
K231913Device Name
T-FIT
Manufacturer
Techwin Co., Ltd.
Date Cleared
2024-02-08
(224 days)
Product Code
OAT
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Techwin Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The T-FIT is designed to provide a fixed anchorage point for attaching orthodontic appliances, facilitating the orthodontic movement of teeth. It is used temporarily and removed upon completion of the orthodontic treatment for use in patients aged 12 and older. The screws are intended for single use only.
Device Description
The T-FIT is designed to serve as a fixed anchorage point for attaching orthodontic appliances to facilitate the movement of teeth during orthodontic treatment. The system is intended for temporary use and is removed once treatment is complete. The T-FIT is available in thread diameters Ø1.4 mm, 1.6 mm, and 2.0 mm and thread lengths of 6.0 mm, 8.0 mm, 10.0 mm, 12.0 mm, and 14.0 mm. Thread lengths of 12.0 mm and 14.0 mm are only available with Ø2.0 mm diameter models. All screws are manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F 136-13). The T-FIT is provided non-sterile and is intended for single use only. Additionally, the T-FIT is designed to be used with commonly available dental surgical instruments.
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