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FDA 510(k)

ONE COAT SE BOND

K-Number: K033760 · 2004-01-23

ApplicantColtene/Whaledent, Inc.
Decision Date2004-01-23
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ONE COAT SE BOND 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 2004-01-23 under 510(k) number K033760. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONE COAT SE BOND?

ONE COAT SE BOND is a medical device that received FDA 510(k) clearance on 2004-01-23. The listed applicant is Coltene/Whaledent, Inc.. The 510(k) number is K033760.

When did ONE COAT SE BOND receive FDA 510(k) clearance?

ONE COAT SE BOND received FDA 510(k) clearance on 2004-01-23, under 510(k) number K033760.

Who is the listed applicant for ONE COAT SE BOND?

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 ONE COAT SE BOND?

The FDA product code for ONE COAT SE BOND is KLE.

Other records listing Coltene/Whaledent, Inc. 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.

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Related Devices (Code: KLE)

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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