FDA 510(k)

BBX1, BBX2, BBX1MO, BBX1MC

K-Number: K142846 · 2016-09-08

Decision Date2016-09-08

Product CodeDZE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

BBX1, BBX2, BBX1MO, BBX1MC is the device name listed in this FDA 510(k) record. The listed applicant is Globaldental, Inc.. It received FDA 510(k) clearance on 2016-09-08 under 510(k) number K142846. 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 BBX1, BBX2, BBX1MO, BBX1MC?

BBX1, BBX2, BBX1MO, BBX1MC is a medical device that received FDA 510(k) clearance on 2016-09-08. The listed applicant is Globaldental, Inc.. The 510(k) number is K142846.

When did BBX1, BBX2, BBX1MO, BBX1MC receive FDA 510(k) clearance?

BBX1, BBX2, BBX1MO, BBX1MC received FDA 510(k) clearance on 2016-09-08, under 510(k) number K142846.

Who is the listed applicant for BBX1, BBX2, BBX1MO, BBX1MC?

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

What is the FDA product code for BBX1, BBX2, BBX1MO, BBX1MC?

The FDA product code for BBX1, BBX2, BBX1MO, BBX1MC is DZE.

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 AB K252031Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.