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FDA 510(k)

CERAPALL 6 -- MODIFIED

K-Number: K924292 · 1993-03-01

ApplicantMetalor Dental USA Corp.
Decision Date1993-03-01
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CERAPALL 6 -- MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Metalor Dental USA Corp.. It received FDA 510(k) clearance on 1993-03-01 under 510(k) number K924292. 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 CERAPALL 6 -- MODIFIED?

CERAPALL 6 -- MODIFIED is a medical device that received FDA 510(k) clearance on 1993-03-01. The listed applicant is Metalor Dental USA Corp.. The 510(k) number is K924292.

When did CERAPALL 6 -- MODIFIED receive FDA 510(k) clearance?

CERAPALL 6 -- MODIFIED received FDA 510(k) clearance on 1993-03-01, under 510(k) number K924292.

Who is the listed applicant for CERAPALL 6 -- MODIFIED?

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

What is the FDA product code for CERAPALL 6 -- MODIFIED?

The FDA product code for CERAPALL 6 -- MODIFIED is EJS.

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Other records listing Metalor Dental USA 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.

K003387AUROFILM NPK993475AUROFLUID M, ALLOY NO. 5315K993505V-DELTA SPECIAL, ALLOY NO. 5154K993506PAGALINOR 4 , ALLOY NO. 5440K993507V-SUPRAGOLD, ALLOY NO. 5024K993508V-SUPRA PLUS, ALLOY NO. 5025

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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

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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