Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

QUAD Dental Implants and Prostheses

K-Number: K152188 · 2016-01-28

ApplicantDentack Impants, Ltd.
Decision Date2016-01-28
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

QUAD Dental Implants and Prostheses is the device name listed in this FDA 510(k) record. The listed applicant is Dentack Impants, Ltd.. It received FDA 510(k) clearance on 2016-01-28 under 510(k) number K152188. 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 QUAD Dental Implants and Prostheses?

QUAD Dental Implants and Prostheses is a medical device that received FDA 510(k) clearance on 2016-01-28. The listed applicant is Dentack Impants, Ltd.. The 510(k) number is K152188.

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

QUAD Dental Implants and Prostheses received FDA 510(k) clearance on 2016-01-28, under 510(k) number K152188.

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

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

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

The FDA product code for QUAD Dental Implants and Prostheses 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.

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.

↑