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FDA 510(k)

PANORAMIC X-RAY UNIT (MODIFICATION)

K-Number: K952763 · 1995-10-07

ApplicantPlanmeca Oy
Decision Date1995-10-07
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PANORAMIC X-RAY UNIT (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Planmeca Oy. It received FDA 510(k) clearance on 1995-10-07 under 510(k) number K952763. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PANORAMIC X-RAY UNIT (MODIFICATION)?

PANORAMIC X-RAY UNIT (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1995-10-07. The listed applicant is Planmeca Oy. The 510(k) number is K952763.

When did PANORAMIC X-RAY UNIT (MODIFICATION) receive FDA 510(k) clearance?

PANORAMIC X-RAY UNIT (MODIFICATION) received FDA 510(k) clearance on 1995-10-07, under 510(k) number K952763.

Who is the listed applicant for PANORAMIC X-RAY UNIT (MODIFICATION)?

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

What is the FDA product code for PANORAMIC X-RAY UNIT (MODIFICATION)?

The FDA product code for PANORAMIC X-RAY UNIT (MODIFICATION) is EHD.

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Other records listing Planmeca 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.

K230985Planmeca VisoK200572Planmeca RomexisK181576Planmeca VisoK171385Planmeca RomexisK160506Planmeca ProMax 3D Max, Planmeca MaximityK103689PLANMECA PROMAX 3D MID

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Related Devices (Code: EHD)

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.

K260795Hand-held Dental X-ray System (HyperLight-M)Changzhou Sifary Medical Technology Co., Ltd.K260367Portable Dental X-ray System Model PDX novaPDX Co., Ltd.K253864NOMAD Pro 3Dental Imaging Technologies CorporationK252110Dental X-RAY Unit (AJX200)Guangzhou Ajax Medical Equipment Co., Ltd.K254018Portable Dental X-ray Device (GT-1)Guilin Refine Medical Instrument Co., Ltd.K252909Diagnostic X-Ray Equipment Model POCT22Ningbo Runyes Medical Instrument Co., Ltd.

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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