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FDA 510(k)

A.B. DENTAL DEVICES Dental Implants System

K-Number: K162482 · 2017-09-15

ApplicantA.B. Dental Device , Ltd.
Decision Date2017-09-15
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

A.B. DENTAL DEVICES Dental Implants System is a medical device manufactured by A.B. Dental Device , Ltd.. It received FDA 510(k) clearance on 2017-09-15 under approval number K162482. 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 A.B. DENTAL DEVICES Dental Implants System?

A.B. DENTAL DEVICES Dental Implants System is a medical device that received FDA 510(k) clearance on 2017-09-15. It is manufactured by A.B. Dental Device , Ltd.. The 510(k) number is K162482.

When was A.B. DENTAL DEVICES Dental Implants System approved by the FDA?

A.B. DENTAL DEVICES Dental Implants System received FDA 510(k) clearance on 2017-09-15, under approval number K162482.

What company makes A.B. DENTAL DEVICES Dental Implants System?

A.B. DENTAL DEVICES Dental Implants System is manufactured by A.B. Dental Device , Ltd..

What is the FDA product code for A.B. DENTAL DEVICES Dental Implants System?

The FDA product code for A.B. DENTAL DEVICES Dental Implants System is DZE.

Related Clinical Trials

NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT07608523 Marginal Bone Level Around Dental Implants in Periodontitis Patients COMPLETED NCT06099015 Cera™ Vascular Plug System Post-Market Clinical Follow-Up RECRUITING NCT07232030 Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure ENROLLING_BY_INVITATION NCT07601503 Evaluating In-line Chlorination in Nigeria NOT_YET_RECRUITING

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) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 42014629 Clinical implementation of an EU MDR-compliant point-of-care manufacturing framework for patient-specific 3D-printed PEEK implants in craniomaxillofacial reconstruction. 3D printing in medicine (2026) PMID: 41947919 Analysis of Trends in FDA-Recalled Hip Arthroplasty Devices: A Retrospective Review. JB & JS open access (2026)

Other Devices by A.B. Dental Device , Ltd.

K181381A.B. Dental Devices Dental Implants System K182455A.B. DENTAL DEVICES Dental Implants System K202144A.B. Dental Devices Dental Implants System

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.

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