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FDA 510(k)

XENO ADHESIVE WITH ACTIVATOR

K-Number: K051463 · 2005-07-12

ApplicantDentsply Intl.
Decision Date2005-07-12
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

XENO ADHESIVE WITH ACTIVATOR is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 2005-07-12 under 510(k) number K051463. 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 ADHESIVE WITH ACTIVATOR?

XENO ADHESIVE WITH ACTIVATOR is a medical device that received FDA 510(k) clearance on 2005-07-12. The listed applicant is Dentsply Intl.. The 510(k) number is K051463.

When did XENO ADHESIVE WITH ACTIVATOR receive FDA 510(k) clearance?

XENO ADHESIVE WITH ACTIVATOR received FDA 510(k) clearance on 2005-07-12, under 510(k) number K051463.

Who is the listed applicant for XENO ADHESIVE WITH ACTIVATOR?

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 ADHESIVE WITH ACTIVATOR?

The FDA product code for XENO ADHESIVE WITH ACTIVATOR 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.

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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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