Clearance Summary
Dental Implant Unit received FDA 510(k) clearance under submission number K242646, sponsored by Guilin Aesthedent Medical Instruments Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2025-04-11.
- Submission: K242646
- Applicant / Sponsor: Guilin Aesthedent Medical Instruments Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2025-04-11
Classification & Regulation
This clearance is catalogued under FDA product code EBW and 21 CFR 872.4200, within the Dental review panel as a Class I device.