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FDA 510(k)

DW 215-12A ALLOY FOR FORCELAIN FUSED TO METAL

K-Number: K920613 · 1992-04-21

ApplicantIvoclar North America, Inc.
Decision Date1992-04-21
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DW 215-12A ALLOY FOR FORCELAIN FUSED TO METAL is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar North America, Inc.. It received FDA 510(k) clearance on 1992-04-21 under 510(k) number K920613. 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 DW 215-12A ALLOY FOR FORCELAIN FUSED TO METAL?

DW 215-12A ALLOY FOR FORCELAIN FUSED TO METAL is a medical device that received FDA 510(k) clearance on 1992-04-21. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K920613.

When did DW 215-12A ALLOY FOR FORCELAIN FUSED TO METAL receive FDA 510(k) clearance?

DW 215-12A ALLOY FOR FORCELAIN FUSED TO METAL received FDA 510(k) clearance on 1992-04-21, under 510(k) number K920613.

Who is the listed applicant for DW 215-12A ALLOY FOR FORCELAIN FUSED TO METAL?

The FDA 510(k) record lists Ivoclar North America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DW 215-12A ALLOY FOR FORCELAIN FUSED TO METAL?

The FDA product code for DW 215-12A ALLOY FOR FORCELAIN FUSED TO METAL is EJS.

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Other records listing Ivoclar North America, Inc. 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.

K012174ERIS LAYERING MATERIALSK011491HELIOSEAL CLEAR CHROMAK011492IN TEN-SK011490MODIFICATION TO EXCITEK011023D.SIGN 96K011022BIOUNIVERSAL PDF

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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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