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FDA 510(k)

Dental Implant Unit

K-Number: K242646 · 2025-04-11

ApplicantGuilin Aesthedent Medical Instruments Co., Ltd.
Decision Date2025-04-11
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental Implant Unit is a medical device manufactured by Guilin Aesthedent Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2025-04-11 under approval number K242646. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dental Implant Unit?

Dental Implant Unit is a medical device that received FDA 510(k) clearance on 2025-04-11. It is manufactured by Guilin Aesthedent Medical Instruments Co., Ltd.. The 510(k) number is K242646.

When was Dental Implant Unit approved by the FDA?

Dental Implant Unit received FDA 510(k) clearance on 2025-04-11, under approval number K242646.

What company makes Dental Implant Unit?

Dental Implant Unit is manufactured by Guilin Aesthedent Medical Instruments Co., Ltd..

What is the FDA product code for Dental Implant Unit?

The FDA product code for Dental Implant Unit is EBW.

Related Clinical Trials

NCT07605286 Soft Tissue Augmentation Around Dental Implants COMPLETED NCT07589140 Influence of Alveolar Bone Drilling and Anatomical Position on Integration NOT_YET_RECRUITING NCT07246499 Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues. ACTIVE_NOT_RECRUITING NCT07240493 BMP Effect on Implant Stability and Marginal Bone Level After Immediate Placement COMPLETED NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED NCT07580495 Effect of Collagen Membrane on Ridge Preservation NOT_YET_RECRUITING

Related Devices (Code: EBW)

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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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