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FDA 510(k)

DW 235

K-Number: K905205 · 1990-12-17

ApplicantIvoclar North America, Inc.
Decision Date1990-12-17
Product CodeEJJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DW 235 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 1990-12-17 under 510(k) number K905205. The device is classified under product code EJJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DW 235?

DW 235 is a medical device that received FDA 510(k) clearance on 1990-12-17. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K905205.

When did DW 235 receive FDA 510(k) clearance?

DW 235 received FDA 510(k) clearance on 1990-12-17, under 510(k) number K905205.

Who is the listed applicant for DW 235?

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 235?

The FDA product code for DW 235 is EJJ.

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: EJJ)

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.

K053114SILVERFILDunia Perwira Manufacturing Sdn. Bhd.K051010SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70SeptodontK033434BESTALOYWe Dong Myung Dental Industrial Co., Ltd.K032152BENCO ADMIXSouthern Dental Industries, Inc.K031658BENCO SPHERICALSouthern Dental Industries, Inc.K020452HIGH SILVER CONVENTIONALAb Ardent

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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