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FDA 510(k)

NEW DENTIN PRIMER

K-Number: K930504 · 1993-05-27

ApplicantDentsply Intl.
Decision Date1993-05-27
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NEW DENTIN PRIMER is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1993-05-27 under 510(k) number K930504. 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 NEW DENTIN PRIMER?

NEW DENTIN PRIMER is a medical device that received FDA 510(k) clearance on 1993-05-27. The listed applicant is Dentsply Intl.. The 510(k) number is K930504.

When did NEW DENTIN PRIMER receive FDA 510(k) clearance?

NEW DENTIN PRIMER received FDA 510(k) clearance on 1993-05-27, under 510(k) number K930504.

Who is the listed applicant for NEW DENTIN PRIMER?

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 NEW DENTIN PRIMER?

The FDA product code for NEW DENTIN PRIMER 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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