Customized Abutment and Screw
K-Number: K242768 · 2025-09-02
Decision Date2025-09-02
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Customized Abutment and Screw is a medical device manufactured by Chengdu Besmile Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-09-02 under approval number K242768. 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 Customized Abutment and Screw?
Customized Abutment and Screw is a medical device that received FDA 510(k) clearance on 2025-09-02. It is manufactured by Chengdu Besmile Medical Technology Co., Ltd.. The 510(k) number is K242768.
When was Customized Abutment and Screw approved by the FDA?
Customized Abutment and Screw received FDA 510(k) clearance on 2025-09-02, under approval number K242768.
What company makes Customized Abutment and Screw?
Customized Abutment and Screw is manufactured by Chengdu Besmile Medical Technology Co., Ltd..
What is the FDA product code for Customized Abutment and Screw?
The FDA product code for Customized Abutment and Screw is NHA.
Related Clinical Trials
Other Devices by Chengdu Besmile Medical Technology Co., Ltd.
Related Devices (Code: NHA)
K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.
K160798IPS e.max® Press Abutment Solutions for Viteo Base TiIvoclar Vivadent, AG
K162004PREMIUM Implant Systems SHELTA Implant SystemsSweden & Martina S.P.A.
K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd.
K161435Temporary Snap AbutmentNobel Biocare AB
K160786RODO Abutment SystemRodo Medical, Inc.
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.