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FDA 510(k)

PARAPOST FIBER WHITE

K-Number: K000311 · 2000-03-14

ApplicantColtene/Whaledent, Inc.
Decision Date2000-03-14
Product CodeELR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PARAPOST FIBER WHITE is the device name listed in this FDA 510(k) record. The listed applicant is Coltene/Whaledent, Inc.. It received FDA 510(k) clearance on 2000-03-14 under 510(k) number K000311. The device is classified under product code ELR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARAPOST FIBER WHITE?

PARAPOST FIBER WHITE is a medical device that received FDA 510(k) clearance on 2000-03-14. The listed applicant is Coltene/Whaledent, Inc.. The 510(k) number is K000311.

When did PARAPOST FIBER WHITE receive FDA 510(k) clearance?

PARAPOST FIBER WHITE received FDA 510(k) clearance on 2000-03-14, under 510(k) number K000311.

Who is the listed applicant for PARAPOST FIBER WHITE?

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

What is the FDA product code for PARAPOST FIBER WHITE?

The FDA product code for PARAPOST FIBER WHITE is ELR.

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Other records listing Coltene/Whaledent, Inc. as applicant

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Related Devices (Code: ELR)

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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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