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FDA 510(k)

QUADRANT UNIT-1-BOND

K-Number: K042806 · 2004-11-24

ApplicantCavex Holland BV
Decision Date2004-11-24
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

QUADRANT UNIT-1-BOND 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 2004-11-24 under 510(k) number K042806. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUADRANT UNIT-1-BOND?

QUADRANT UNIT-1-BOND is a medical device that received FDA 510(k) clearance on 2004-11-24. The listed applicant is Cavex Holland BV. The 510(k) number is K042806.

When did QUADRANT UNIT-1-BOND receive FDA 510(k) clearance?

QUADRANT UNIT-1-BOND received FDA 510(k) clearance on 2004-11-24, under 510(k) number K042806.

Who is the listed applicant for QUADRANT UNIT-1-BOND?

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 QUADRANT UNIT-1-BOND?

The FDA product code for QUADRANT UNIT-1-BOND is KLE.

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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.

K073539PROVISA CEMK072245EMULATE ADVANCEDK062400IMPRESSIX, COLORCHANGE ALGINATEK061267SIMULATE, COLOR CHANGE ALGINATEK052455IMPRESSIXK051207CAVEX ORTHOTRACE

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Related Devices (Code: KLE)

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.

K262252MPa Max adhesiveDen-Mat Holdings, LLCK260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.

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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