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FDA 510(k)

PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID

K-Number: K110037 · 2011-04-29

ApplicantHeraeus Kulzer, LLC
Decision Date2011-04-29
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS 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 2011-04-29 under 510(k) number K110037. 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 PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID?

PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID is a medical device that received FDA 510(k) clearance on 2011-04-29. The listed applicant is Heraeus Kulzer, LLC. The 510(k) number is K110037.

When did PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID receive FDA 510(k) clearance?

PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID received FDA 510(k) clearance on 2011-04-29, under 510(k) number K110037.

Who is the listed applicant for PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS 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 PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID?

The FDA product code for PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS 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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