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FDA 510(k)

PRE-IMPRESSION CONDITIONING SOLUTION

K-Number: K061427 · 2006-06-26

ApplicantDentsply Intl.
Decision Date2006-06-26
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRE-IMPRESSION CONDITIONING SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 2006-06-26 under 510(k) number K061427. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRE-IMPRESSION CONDITIONING SOLUTION?

PRE-IMPRESSION CONDITIONING SOLUTION is a medical device that received FDA 510(k) clearance on 2006-06-26. The listed applicant is Dentsply Intl.. The 510(k) number is K061427.

When did PRE-IMPRESSION CONDITIONING SOLUTION receive FDA 510(k) clearance?

PRE-IMPRESSION CONDITIONING SOLUTION received FDA 510(k) clearance on 2006-06-26, under 510(k) number K061427.

Who is the listed applicant for PRE-IMPRESSION CONDITIONING SOLUTION?

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 PRE-IMPRESSION CONDITIONING SOLUTION?

The FDA product code for PRE-IMPRESSION CONDITIONING SOLUTION is ELW.

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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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