FDA 510(k)

DW243-64

K-Number: K923644 · 1992-11-04

Decision Date1992-11-04

Product CodeEJS

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

DW243-64 is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar USA, Inc.. It received FDA 510(k) clearance on 1992-11-04 under 510(k) number K923644. 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 DW243-64?

DW243-64 is a medical device that received FDA 510(k) clearance on 1992-11-04. The listed applicant is Ivoclar USA, Inc.. The 510(k) number is K923644.

When did DW243-64 receive FDA 510(k) clearance?

DW243-64 received FDA 510(k) clearance on 1992-11-04, under 510(k) number K923644.

Who is the listed applicant for DW243-64?

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

What is the FDA product code for DW243-64?

The FDA product code for DW243-64 is EJS.

Other records listing Ivoclar USA, 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.

K012877HIGH GOLD PALLADIUM FREE CERAMIC SOLDER K981264ARISTON PHC K980986PROCAD K941849PROVIPONT C&B K864708SR 3/60 NF DENTURE MATER. & SELF-CURE DENT. RESIN K864710ISOSIT N

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Related Devices (Code: EJS)

K041433BRIGHT GOLD XHIvoclar Vivadent, Inc.K040436SIMIDUR SUPERIORWieland Dental + Technik GmbH & Co. KG K022252STERNGOLD 1, MODEL 1127781Sterngold K022469ECO E4Wieland Dental + Technik GmbH & Co. KG K021367STERNGOLD 66, MODEL #1180230Sterngold K020195SIMIDUR 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.