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FDA 510(k)

FLUORIDE-PSA PRIME/ADHESIVE

K-Number: K941572 · 1994-06-10

ApplicantDentsply Intl.
Decision Date1994-06-10
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FLUORIDE-PSA PRIME/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 1994-06-10 under 510(k) number K941572. 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 FLUORIDE-PSA PRIME/ADHESIVE?

FLUORIDE-PSA PRIME/ADHESIVE is a medical device that received FDA 510(k) clearance on 1994-06-10. The listed applicant is Dentsply Intl.. The 510(k) number is K941572.

When did FLUORIDE-PSA PRIME/ADHESIVE receive FDA 510(k) clearance?

FLUORIDE-PSA PRIME/ADHESIVE received FDA 510(k) clearance on 1994-06-10, under 510(k) number K941572.

Who is the listed applicant for FLUORIDE-PSA PRIME/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 FLUORIDE-PSA PRIME/ADHESIVE?

The FDA product code for FLUORIDE-PSA PRIME/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.

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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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