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)

Panoura X-ERA PF/NF/MF

K-Number: K182198 · 2019-01-31

ApplicantThe Yoshida Dental Mfg. Co., Ltd.
Decision Date2019-01-31
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Panoura X-ERA PF/NF/MF is the device name listed in this FDA 510(k) record. The listed applicant is The Yoshida Dental Mfg. Co., Ltd.. It received FDA 510(k) clearance on 2019-01-31 under 510(k) number K182198. 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 Panoura X-ERA PF/NF/MF?

Panoura X-ERA PF/NF/MF is a medical device that received FDA 510(k) clearance on 2019-01-31. The listed applicant is The Yoshida Dental Mfg. Co., Ltd.. The 510(k) number is K182198.

When did Panoura X-ERA PF/NF/MF receive FDA 510(k) clearance?

Panoura X-ERA PF/NF/MF received FDA 510(k) clearance on 2019-01-31, under 510(k) number K182198.

Who is the listed applicant for Panoura X-ERA PF/NF/MF?

The FDA 510(k) record lists The Yoshida Dental Mfg. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Panoura X-ERA PF/NF/MF?

The FDA product code for Panoura X-ERA PF/NF/MF 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

View on FDA Database →

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

↑