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FDA 510(k)

PANOREX II DENTAL X-RAY UNIT

K-Number: K800133 · 1980-03-03

ApplicantPennwalt Corp.
Decision Date1980-03-03
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PANOREX II DENTAL X-RAY UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Pennwalt Corp.. It received FDA 510(k) clearance on 1980-03-03 under 510(k) number K800133. 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 PANOREX II DENTAL X-RAY UNIT?

PANOREX II DENTAL X-RAY UNIT is a medical device that received FDA 510(k) clearance on 1980-03-03. The listed applicant is Pennwalt Corp.. The 510(k) number is K800133.

When did PANOREX II DENTAL X-RAY UNIT receive FDA 510(k) clearance?

PANOREX II DENTAL X-RAY UNIT received FDA 510(k) clearance on 1980-03-03, under 510(k) number K800133.

Who is the listed applicant for PANOREX II DENTAL X-RAY UNIT?

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

What is the FDA product code for PANOREX II DENTAL X-RAY UNIT?

The FDA product code for PANOREX II DENTAL X-RAY UNIT is EHD.

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Other records listing Pennwalt Corp. 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.

K833241INTREXK801860S.S. WHITE-PENNWALT RENEW CALCIUM HYDROXK801274S.S. WHITE-PENNWALT PRELUDE PIT SEALANTK800063XR-710K780981PORTABLE PNEUMATIC CALIBRATOR 65-150

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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