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FDA 510(k)

STAY-PUT IMPREGNATED

K-Number: K041023 · 2004-06-15

ApplicantColtene/Whaledent GmbH & Co. KG
Decision Date2004-06-15
Product CodeMVL
DecisionSubstantially Equivalent

Device Summary

STAY-PUT IMPREGNATED is the device name listed in this FDA 510(k) record. The listed applicant is Coltene/Whaledent GmbH & Co. KG. It received FDA 510(k) clearance on 2004-06-15 under 510(k) number K041023. The device is classified under product code MVL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAY-PUT IMPREGNATED?

STAY-PUT IMPREGNATED is a medical device that received FDA 510(k) clearance on 2004-06-15. The listed applicant is Coltene/Whaledent GmbH & Co. KG. The 510(k) number is K041023.

When did STAY-PUT IMPREGNATED receive FDA 510(k) clearance?

STAY-PUT IMPREGNATED received FDA 510(k) clearance on 2004-06-15, under 510(k) number K041023.

Who is the listed applicant for STAY-PUT IMPREGNATED?

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

What is the FDA product code for STAY-PUT IMPREGNATED?

The FDA product code for STAY-PUT IMPREGNATED is MVL.

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Other records listing Coltene/Whaledent GmbH & Co. KG as applicant

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.

K032662GUTTAFLOW

Related Devices (Code: MVL)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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