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FDA 510(k)

PRIME & BOND DIRECT COMPOSITE BONDING AGENT

K-Number: K951864 · 1995-05-23

ApplicantDentsply Intl.
Decision Date1995-05-23
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRIME & BOND DIRECT COMPOSITE BONDING AGENT is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1995-05-23 under 510(k) number K951864. 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 PRIME & BOND DIRECT COMPOSITE BONDING AGENT?

PRIME & BOND DIRECT COMPOSITE BONDING AGENT is a medical device that received FDA 510(k) clearance on 1995-05-23. The listed applicant is Dentsply Intl.. The 510(k) number is K951864.

When did PRIME & BOND DIRECT COMPOSITE BONDING AGENT receive FDA 510(k) clearance?

PRIME & BOND DIRECT COMPOSITE BONDING AGENT received FDA 510(k) clearance on 1995-05-23, under 510(k) number K951864.

Who is the listed applicant for PRIME & BOND DIRECT COMPOSITE BONDING AGENT?

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 PRIME & BOND DIRECT COMPOSITE BONDING AGENT?

The FDA product code for PRIME & BOND DIRECT COMPOSITE BONDING AGENT 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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