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FDA 510(k)

ODI HD Dental Sensor

K-Number: K190234 · 2019-03-01

ApplicantCnd Global Technologies, Inc.
Decision Date2019-03-01
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ODI HD Dental Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Cnd Global Technologies, Inc.. It received FDA 510(k) clearance on 2019-03-01 under 510(k) number K190234. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ODI HD Dental Sensor?

ODI HD Dental Sensor is a medical device that received FDA 510(k) clearance on 2019-03-01. The listed applicant is Cnd Global Technologies, Inc.. The 510(k) number is K190234.

When did ODI HD Dental Sensor receive FDA 510(k) clearance?

ODI HD Dental Sensor received FDA 510(k) clearance on 2019-03-01, under 510(k) number K190234.

Who is the listed applicant for ODI HD Dental Sensor?

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

What is the FDA product code for ODI HD Dental Sensor?

The FDA product code for ODI HD Dental Sensor is MUH.

Related Devices (Code: MUH)

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.

K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.K250687Cocoon Solo (DX-7020s)Dexcowin Global, Inc.K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc.K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)VATECH Co., Ltd.K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)Qpix Solutions, Inc.

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.

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