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FDA 510(k)

QUADRANT UNIBOND

K-Number: K983545 · 1998-11-18

ApplicantCavex Holland BV
Decision Date1998-11-18
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

QUADRANT UNIBOND 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 1998-11-18 under 510(k) number K983545. 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 UNIBOND?

QUADRANT UNIBOND is a medical device that received FDA 510(k) clearance on 1998-11-18. The listed applicant is Cavex Holland BV. The 510(k) number is K983545.

When did QUADRANT UNIBOND receive FDA 510(k) clearance?

QUADRANT UNIBOND received FDA 510(k) clearance on 1998-11-18, under 510(k) number K983545.

Who is the listed applicant for QUADRANT UNIBOND?

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 UNIBOND?

The FDA product code for QUADRANT UNIBOND 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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