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FDA 510(k)

SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER)

K-Number: K003407 · 2001-01-26

ApplicantIvoclar North America, Inc.
Decision Date2001-01-26
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER) 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 2001-01-26 under 510(k) number K003407. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER)?

SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER) is a medical device that received FDA 510(k) clearance on 2001-01-26. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K003407.

When did SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER) receive FDA 510(k) clearance?

SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER) received FDA 510(k) clearance on 2001-01-26, under 510(k) number K003407.

Who is the listed applicant for SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER)?

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 SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER)?

The FDA product code for SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER) is EMA.

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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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Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

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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