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FDA 510(k)

TDS (TECHWIN DENTAL SYSTEM)

K-Number: K231932 · 2024-08-20

ApplicantTechwin Co., Ltd.
Decision Date2024-08-20
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TDS (TECHWIN DENTAL SYSTEM) is a medical device manufactured by Techwin Co., Ltd.. It received FDA 510(k) clearance on 2024-08-20 under approval number K231932. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TDS (TECHWIN DENTAL SYSTEM)?

TDS (TECHWIN DENTAL SYSTEM) is a medical device that received FDA 510(k) clearance on 2024-08-20. It is manufactured by Techwin Co., Ltd.. The 510(k) number is K231932.

When was TDS (TECHWIN DENTAL SYSTEM) approved by the FDA?

TDS (TECHWIN DENTAL SYSTEM) received FDA 510(k) clearance on 2024-08-20, under approval number K231932.

What company makes TDS (TECHWIN DENTAL SYSTEM)?

TDS (TECHWIN DENTAL SYSTEM) is manufactured by Techwin Co., Ltd..

What is the FDA product code for TDS (TECHWIN DENTAL SYSTEM)?

The FDA product code for TDS (TECHWIN DENTAL SYSTEM) is NHA.

Related Clinical Trials

NCT07585812 Comfort-in Needle-Free Injection System in Pediatric Dental Anesthesia COMPLETED NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT07581249 This Study Evaluate the Patient Response to Jet Injection, Pain and Satisfaction Compared to Conventional Method of Local Anasthesia Especially in Maxillary Teeth COMPLETED NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED NCT06970171 Acceptance of Mandibular Advancement Devices ENROLLING_BY_INVITATION NCT05498662 An Observational Study of the T3 Pro Dental Implant System ACTIVE_NOT_RECRUITING

Other Devices by Techwin Co., Ltd.

K231913T-FIT

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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