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FDA 510(k)

DENTAL X-RAY UNIT

K-Number: K932111 · 1994-01-25

ApplicantCastellini S.P.A.
Decision Date1994-01-25
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL X-RAY UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Castellini S.P.A.. It received FDA 510(k) clearance on 1994-01-25 under 510(k) number K932111. 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 X-RAY UNIT?

DENTAL X-RAY UNIT is a medical device that received FDA 510(k) clearance on 1994-01-25. The listed applicant is Castellini S.P.A.. The 510(k) number is K932111.

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

DENTAL X-RAY UNIT received FDA 510(k) clearance on 1994-01-25, under 510(k) number K932111.

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

The FDA 510(k) record lists Castellini S.P.A. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

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.

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Other records listing Castellini S.P.A. 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.

K023513LOGOS JUNIOR DENTAL CHAIR AND UNITK000834CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTOK000837PUMA DENTAL CHAIR AND UNIT

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

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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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