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FDA 510(k)

BBX1, BBX2, BBX1MO, BBX1MC

K-Number: K142846 · 2016-09-08

ApplicantGlobaldental, Inc.
Decision Date2016-09-08
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BBX1, BBX2, BBX1MO, BBX1MC is a medical device manufactured by Globaldental, Inc.. It received FDA 510(k) clearance on 2016-09-08 under approval 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. It is manufactured by Globaldental, Inc.. The 510(k) number is K142846.

When was BBX1, BBX2, BBX1MO, BBX1MC approved by the FDA?

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

What company makes BBX1, BBX2, BBX1MO, BBX1MC?

BBX1, BBX2, BBX1MO, BBX1MC is manufactured by Globaldental, Inc..

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)

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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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