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FDA 510(k)

PYRAMIDION Dental Implants and Prostheses

K-Number: K180859 · 2018-12-13

ApplicantDentack Implants, Ltd.
Decision Date2018-12-13
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PYRAMIDION Dental Implants and Prostheses is the device name listed in this FDA 510(k) record. The listed applicant is Dentack Implants, Ltd.. It received FDA 510(k) clearance on 2018-12-13 under 510(k) number K180859. 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 PYRAMIDION Dental Implants and Prostheses?

PYRAMIDION Dental Implants and Prostheses is a medical device that received FDA 510(k) clearance on 2018-12-13. The listed applicant is Dentack Implants, Ltd.. The 510(k) number is K180859.

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

PYRAMIDION Dental Implants and Prostheses received FDA 510(k) clearance on 2018-12-13, under 510(k) number K180859.

Who is the listed applicant for PYRAMIDION Dental Implants and Prostheses?

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

What is the FDA product code for PYRAMIDION Dental Implants and Prostheses?

The FDA product code for PYRAMIDION Dental Implants and Prostheses is DZE.

Related Clinical Trials

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NCT06533397The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor ElevationRECRUITINGNCT07212855Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge ProtocolCOMPLETEDNCT07574099Loading Protocols for Dental Implants Placed in Healed Fully Edentulous MaxillaACTIVE_NOT_RECRUITINGNCT07763431Home-Use Dual-Light Antibacterial Photodynamic Therapy for Peri-Implant Mucositis in Full-Arch Implant ProsthesesNOT_YET_RECRUITING

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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