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FDA 510(k)

V-DELTA S1

K-Number: K912315 · 1991-07-02

ApplicantMetalor Dental USA Corp.
Decision Date1991-07-02
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

V-DELTA 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 1991-07-02 under 510(k) number K912315. 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 V-DELTA S1?

V-DELTA S1 is a medical device that received FDA 510(k) clearance on 1991-07-02. The listed applicant is Metalor Dental USA Corp.. The 510(k) number is K912315.

When did V-DELTA S1 receive FDA 510(k) clearance?

V-DELTA S1 received FDA 510(k) clearance on 1991-07-02, under 510(k) number K912315.

Who is the listed applicant for V-DELTA 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 V-DELTA S1?

The FDA product code for V-DELTA 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. 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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