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FDA 510(k)

XENO NM LIGHT CURED DENTAL ADHESIVE

K-Number: K041343 · 2004-06-16

ApplicantDentsply International
Decision Date2004-06-16
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

XENO NM LIGHT CURED DENTAL ADHESIVE is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply International. It received FDA 510(k) clearance on 2004-06-16 under 510(k) number K041343. 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 NM LIGHT CURED DENTAL ADHESIVE?

XENO NM LIGHT CURED DENTAL ADHESIVE is a medical device that received FDA 510(k) clearance on 2004-06-16. The listed applicant is Dentsply International. The 510(k) number is K041343.

When did XENO NM LIGHT CURED DENTAL ADHESIVE receive FDA 510(k) clearance?

XENO NM LIGHT CURED DENTAL ADHESIVE received FDA 510(k) clearance on 2004-06-16, under 510(k) number K041343.

Who is the listed applicant for XENO NM LIGHT CURED DENTAL ADHESIVE?

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

What is the FDA product code for XENO NM LIGHT CURED DENTAL ADHESIVE?

The FDA product code for XENO NM LIGHT CURED DENTAL ADHESIVE is KLE.

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Other records listing Dentsply International as applicant

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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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