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FDA 510(k)

SR-IVOCAP PLUS

K-Number: K915377 · 1992-01-31

ApplicantIvoclar North America, Inc.
Decision Date1992-01-31
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SR-IVOCAP PLUS 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 1992-01-31 under 510(k) number K915377. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SR-IVOCAP PLUS?

SR-IVOCAP PLUS is a medical device that received FDA 510(k) clearance on 1992-01-31. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K915377.

When did SR-IVOCAP PLUS receive FDA 510(k) clearance?

SR-IVOCAP PLUS received FDA 510(k) clearance on 1992-01-31, under 510(k) number K915377.

Who is the listed applicant for SR-IVOCAP PLUS?

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 SR-IVOCAP PLUS?

The FDA product code for SR-IVOCAP PLUS is EBI.

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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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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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