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FDA 510(k)

PARAPOST PARACORE AUTOMIX 5ML

K-Number: K052820 · 2006-01-09

ApplicantColtene/Whaledent AG
Decision Date2006-01-09
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PARAPOST PARACORE AUTOMIX 5ML is the device name listed in this FDA 510(k) record. The listed applicant is Coltene/Whaledent AG. It received FDA 510(k) clearance on 2006-01-09 under 510(k) number K052820. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARAPOST PARACORE AUTOMIX 5ML?

PARAPOST PARACORE AUTOMIX 5ML is a medical device that received FDA 510(k) clearance on 2006-01-09. The listed applicant is Coltene/Whaledent AG. The 510(k) number is K052820.

When did PARAPOST PARACORE AUTOMIX 5ML receive FDA 510(k) clearance?

PARAPOST PARACORE AUTOMIX 5ML received FDA 510(k) clearance on 2006-01-09, under 510(k) number K052820.

Who is the listed applicant for PARAPOST PARACORE AUTOMIX 5ML?

The FDA 510(k) record lists Coltene/Whaledent AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PARAPOST PARACORE AUTOMIX 5ML?

The FDA product code for PARAPOST PARACORE AUTOMIX 5ML is EBF.

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Other records listing Coltene/Whaledent AG as applicant

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Related Devices (Code: EBF)

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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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