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FDA 510(k)

PROVISA CEM

K-Number: K073539 · 2008-01-31

ApplicantCavex Holland BV
Decision Date2008-01-31
Product CodeEMB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROVISA CEM is the device name listed in this FDA 510(k) record. The listed applicant is Cavex Holland BV. It received FDA 510(k) clearance on 2008-01-31 under 510(k) number K073539. The device is classified under product code EMB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROVISA CEM?

PROVISA CEM is a medical device that received FDA 510(k) clearance on 2008-01-31. The listed applicant is Cavex Holland BV. The 510(k) number is K073539.

When did PROVISA CEM receive FDA 510(k) clearance?

PROVISA CEM received FDA 510(k) clearance on 2008-01-31, under 510(k) number K073539.

Who is the listed applicant for PROVISA CEM?

The FDA 510(k) record lists Cavex Holland BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROVISA CEM?

The FDA product code for PROVISA CEM is EMB.

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Other records listing Cavex Holland BV 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.

K072245EMULATE ADVANCEDK062400IMPRESSIX, COLORCHANGE ALGINATEK061267SIMULATE, COLOR CHANGE ALGINATEK052455IMPRESSIXK051207CAVEX ORTHOTRACEK042806QUADRANT UNIT-1-BOND

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Related Devices (Code: EMB)

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.

K161630Provicol QM PlusVoco GmbHK120695DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KITDentist IN A Box Pty., Ltd.K110759TEMPOCEMDmg USA, Inc.K020158NON-EUGENOL TEMPORARY CEMENTJ. Morita USA, Inc.K941066DENTAL 911L.A.F. Industries, Inc.K861681DENTIMEDIC DENTAL EMERGENCY KITDentimedic

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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