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FDA 510(k)

ORTHOPANTOMOGRAPH OP300

K-Number: K093683 · 2010-10-06

ApplicantInstrumentarium Dental, Palodex Group OY
Decision Date2010-10-06
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHOPANTOMOGRAPH OP300 is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentarium Dental, Palodex Group OY. It received FDA 510(k) clearance on 2010-10-06 under 510(k) number K093683. 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 ORTHOPANTOMOGRAPH OP300?

ORTHOPANTOMOGRAPH OP300 is a medical device that received FDA 510(k) clearance on 2010-10-06. The listed applicant is Instrumentarium Dental, Palodex Group OY. The 510(k) number is K093683.

When did ORTHOPANTOMOGRAPH OP300 receive FDA 510(k) clearance?

ORTHOPANTOMOGRAPH OP300 received FDA 510(k) clearance on 2010-10-06, under 510(k) number K093683.

Who is the listed applicant for ORTHOPANTOMOGRAPH OP300?

The FDA 510(k) record lists Instrumentarium Dental, Palodex Group OY as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHOPANTOMOGRAPH OP300?

The FDA product code for ORTHOPANTOMOGRAPH OP300 is MUH.

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Other records listing Instrumentarium Dental, Palodex Group OY 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.

K092591ORTHOPANTOMOGRAPH OP30K081925SNAPSHOTK063837SIGMA M

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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