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FDA 510(k)

DW242-07 NON-PRECIOUS ALLOY F/ PORCELAIN FUS. MET.

K-Number: K920561 · 1992-03-02

ApplicantIvoclar North America, Inc.
Decision Date1992-03-02
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DW242-07 NON-PRECIOUS ALLOY F/ PORCELAIN FUS. MET. 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 1992-03-02 under 510(k) number K920561. The device is classified under product code EJH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DW242-07 NON-PRECIOUS ALLOY F/ PORCELAIN FUS. MET.?

DW242-07 NON-PRECIOUS ALLOY F/ PORCELAIN FUS. MET. is a medical device that received FDA 510(k) clearance on 1992-03-02. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K920561.

When did DW242-07 NON-PRECIOUS ALLOY F/ PORCELAIN FUS. MET. receive FDA 510(k) clearance?

DW242-07 NON-PRECIOUS ALLOY F/ PORCELAIN FUS. MET. received FDA 510(k) clearance on 1992-03-02, under 510(k) number K920561.

Who is the listed applicant for DW242-07 NON-PRECIOUS ALLOY F/ PORCELAIN FUS. MET.?

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 DW242-07 NON-PRECIOUS ALLOY F/ PORCELAIN FUS. MET.?

The FDA product code for DW242-07 NON-PRECIOUS ALLOY F/ PORCELAIN FUS. MET. is EJH.

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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.

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Related Devices (Code: EJH)

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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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