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FDA 510(k)

STANDARD S1

K-Number: K912303 · 1991-06-26

ApplicantMetalor Dental USA Corp.
Decision Date1991-06-26
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STANDARD S1 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 1991-06-26 under 510(k) number K912303. 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 STANDARD S1?

STANDARD S1 is a medical device that received FDA 510(k) clearance on 1991-06-26. The listed applicant is Metalor Dental USA Corp.. The 510(k) number is K912303.

When did STANDARD S1 receive FDA 510(k) clearance?

STANDARD S1 received FDA 510(k) clearance on 1991-06-26, under 510(k) number K912303.

Who is the listed applicant for STANDARD S1?

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 STANDARD S1?

The FDA product code for STANDARD S1 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. 5315K993506PAGALINOR 4 , ALLOY NO. 5440K993505V-DELTA SPECIAL, ALLOY NO. 5154K993507V-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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