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FDA 510(k)

XENO III DENTAL ADHESIVE

K-Number: K023776 · 2003-01-23

ApplicantDentsply Intl.
Decision Date2003-01-23
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

XENO III DENTAL ADHESIVE is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 2003-01-23 under 510(k) number K023776. 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 XENO III DENTAL ADHESIVE?

XENO III DENTAL ADHESIVE is a medical device that received FDA 510(k) clearance on 2003-01-23. The listed applicant is Dentsply Intl.. The 510(k) number is K023776.

When did XENO III DENTAL ADHESIVE receive FDA 510(k) clearance?

XENO III DENTAL ADHESIVE received FDA 510(k) clearance on 2003-01-23, under 510(k) number K023776.

Who is the listed applicant for XENO III DENTAL ADHESIVE?

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

What is the FDA product code for XENO III DENTAL ADHESIVE?

The FDA product code for XENO III DENTAL ADHESIVE is KLE.

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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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