Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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 a medical device manufactured by Dentack Impants, Ltd.. It received FDA 510(k) clearance on 2016-01-28 under approval 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. It is manufactured by Dentack Impants, Ltd.. The 510(k) number is K152188.

When was QUAD Dental Implants and Prostheses approved by the FDA?

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

What company makes QUAD Dental Implants and Prostheses?

QUAD Dental Implants and Prostheses is manufactured by Dentack Impants, Ltd..

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

NCT07608523 Marginal Bone Level Around Dental Implants in Periodontitis Patients COMPLETED 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

Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026)

Related Devices (Code: DZE)

K160475Ritter Dental Implant SystemRitter Implants GmbH & Co. KG K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. K163043Zeramex P6 Dental Implant SystemDentalpoint AG K161497Dental Implants and AbutmentsDitron Precision, Ltd. K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc. K151970KJ Mini Implant SystemKj Meditech Co., 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.

↑