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FDA 510(k)

COLTOSOL F

K-Number: K031752 · 2003-08-05

ApplicantColtene/Whaledent, Inc.
Decision Date2003-08-05
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COLTOSOL F 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 2003-08-05 under 510(k) number K031752. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLTOSOL F?

COLTOSOL F is a medical device that received FDA 510(k) clearance on 2003-08-05. The listed applicant is Coltene/Whaledent, Inc.. The 510(k) number is K031752.

When did COLTOSOL F receive FDA 510(k) clearance?

COLTOSOL F received FDA 510(k) clearance on 2003-08-05, under 510(k) number K031752.

Who is the listed applicant for COLTOSOL F?

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 COLTOSOL F?

The FDA product code for COLTOSOL F is EMA.

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Other records listing Coltene/Whaledent, Inc. as applicant

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Related Devices (Code: EMA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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