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FDA 510(k)

AUROFLUID 22

K-Number: K970044 · 1997-03-05

ApplicantMetalor Dental USA Corp.
Decision Date1997-03-05
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AUROFLUID 22 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 1997-03-05 under 510(k) number K970044. 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 AUROFLUID 22?

AUROFLUID 22 is a medical device that received FDA 510(k) clearance on 1997-03-05. The listed applicant is Metalor Dental USA Corp.. The 510(k) number is K970044.

When did AUROFLUID 22 receive FDA 510(k) clearance?

AUROFLUID 22 received FDA 510(k) clearance on 1997-03-05, under 510(k) number K970044.

Who is the listed applicant for AUROFLUID 22?

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 AUROFLUID 22?

The FDA product code for AUROFLUID 22 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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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. 5315K993506PAGALINOR 4 , ALLOY NO. 5440K993505V-DELTA SPECIAL, ALLOY NO. 5154K993508V-SUPRA PLUS, ALLOY NO. 5025K993507V-SUPRAGOLD, ALLOY NO. 5024

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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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