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FDA 510(k)

DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC

K-Number: K864474 · 1986-11-26

ApplicantPlanmeca USA, Inc.
Decision Date1986-11-26
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC is the device name listed in this FDA 510(k) record. The listed applicant is Planmeca USA, Inc.. It received FDA 510(k) clearance on 1986-11-26 under 510(k) number K864474. 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 DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC?

DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC is a medical device that received FDA 510(k) clearance on 1986-11-26. The listed applicant is Planmeca USA, Inc.. The 510(k) number is K864474.

When did DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC receive FDA 510(k) clearance?

DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC received FDA 510(k) clearance on 1986-11-26, under 510(k) number K864474.

Who is the listed applicant for DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC?

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

What is the FDA product code for DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC?

The FDA product code for DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC is EHD.

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Other records listing Planmeca USA, Inc. 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.

K111361PLANMED NUANCE EXCELK081699PLANMECA SOVEREIGNK923534PM2002 PROLINEK923533ADMARKK923462DELIGHTK923461PM2002 PROLINE, PM2002 PROLINE EC

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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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