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FDA 510(k)

CHEMODENT CERAMIC METAL

K-Number: K791005 · 1979-08-10

ApplicantChemodent Dental Laboratory
Decision Date1979-08-10
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CHEMODENT CERAMIC METAL is the device name listed in this FDA 510(k) record. The listed applicant is Chemodent Dental Laboratory. It received FDA 510(k) clearance on 1979-08-10 under 510(k) number K791005. The device is classified under product code EJS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHEMODENT CERAMIC METAL?

CHEMODENT CERAMIC METAL is a medical device that received FDA 510(k) clearance on 1979-08-10. The listed applicant is Chemodent Dental Laboratory. The 510(k) number is K791005.

When did CHEMODENT CERAMIC METAL receive FDA 510(k) clearance?

CHEMODENT CERAMIC METAL received FDA 510(k) clearance on 1979-08-10, under 510(k) number K791005.

Who is the listed applicant for CHEMODENT CERAMIC METAL?

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

What is the FDA product code for CHEMODENT CERAMIC METAL?

The FDA product code for CHEMODENT CERAMIC METAL is EJS.

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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Related Devices (Code: EJS)

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.

K041433BRIGHT GOLD XHIvoclar Vivadent, Inc.K040436SIMIDUR SUPERIORWieland Dental + Technik GmbH & Co. KGK022252STERNGOLD 1, MODEL 1127781SterngoldK022469ECO E4Wieland Dental + Technik GmbH & Co. KGK021367STERNGOLD 66, MODEL #1180230SterngoldK020195SIMIDUR S1SWieland Dental + Technik GmbH & Co. KG

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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