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FDA 510(k)

Dental Implants and Abutments

K-Number: K243066 · 2024-12-16

ApplicantDitron Dental, Ltd.
Decision Date2024-12-16
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental Implants and Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Ditron Dental, Ltd.. It received FDA 510(k) clearance on 2024-12-16 under 510(k) number K243066. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dental Implants and Abutments?

Dental Implants and Abutments is a medical device that received FDA 510(k) clearance on 2024-12-16. The listed applicant is Ditron Dental, Ltd.. The 510(k) number is K243066.

When did Dental Implants and Abutments receive FDA 510(k) clearance?

Dental Implants and Abutments received FDA 510(k) clearance on 2024-12-16, under 510(k) number K243066.

Who is the listed applicant for Dental Implants and Abutments?

The FDA 510(k) record lists Ditron Dental, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Implants and Abutments?

The FDA product code for Dental Implants and Abutments is DZE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05883202Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental ImplantsSUSPENDEDNCT07246499Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues.COMPLETEDNCT07714265Soft Tissue Augmentation Around Dental Implants Using Connective Tissue Graft, Submerged Tenting Abutment, or Sub-crestal Implant PlacementRECRUITING

Other records listing Ditron Dental, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233231Dental Implants and Abutments

Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd.

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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