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FDA 510(k)

PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID

K-Number: K111832 · 2011-09-29

ApplicantHeraeus Kulzer, LLC
Decision Date2011-09-29
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, LLC. It received FDA 510(k) clearance on 2011-09-29 under 510(k) number K111832. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID?

PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID is a medical device that received FDA 510(k) clearance on 2011-09-29. The listed applicant is Heraeus Kulzer, LLC. The 510(k) number is K111832.

When did PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID receive FDA 510(k) clearance?

PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID received FDA 510(k) clearance on 2011-09-29, under 510(k) number K111832.

Who is the listed applicant for PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID?

The FDA 510(k) record lists Heraeus Kulzer, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID?

The FDA product code for PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID is EBI.

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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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