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FDA 510(k)

X-L (DW228-14A) AND X-LX (DW228-24A)

K-Number: K913070 · 1991-09-13

ApplicantIvoclar North America, Inc.
Decision Date1991-09-13
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

X-L (DW228-14A) AND X-LX (DW228-24A) 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 1991-09-13 under 510(k) number K913070. 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 X-L (DW228-14A) AND X-LX (DW228-24A)?

X-L (DW228-14A) AND X-LX (DW228-24A) is a medical device that received FDA 510(k) clearance on 1991-09-13. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K913070.

When did X-L (DW228-14A) AND X-LX (DW228-24A) receive FDA 510(k) clearance?

X-L (DW228-14A) AND X-LX (DW228-24A) received FDA 510(k) clearance on 1991-09-13, under 510(k) number K913070.

Who is the listed applicant for X-L (DW228-14A) AND X-LX (DW228-24A)?

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 X-L (DW228-14A) AND X-LX (DW228-24A)?

The FDA product code for X-L (DW228-14A) AND X-LX (DW228-24A) is EJS.

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

View all 131 devices →

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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