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)

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 the device name listed in this FDA 510(k) record. The listed applicant is A.B. Dental Device , Ltd.. It received FDA 510(k) clearance on 2017-09-15 under 510(k) 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. The listed applicant is A.B. Dental Device , Ltd.. The 510(k) number is K162482.

When did A.B. DENTAL DEVICES Dental Implants System receive FDA 510(k) clearance?

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

Who is the listed applicant for A.B. DENTAL DEVICES Dental Implants System?

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

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.

Other records listing A.B. Dental Device , 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.

K202144A.B. Dental Devices Dental Implants SystemK182455A.B. DENTAL DEVICES Dental Implants SystemK181381A.B. Dental Devices Dental Implants System

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.

↑