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FDA 510(k)

COLORANT

K-Number: K790438 · 1979-04-10

ApplicantVivadent (Usa), Inc.
Decision Date1979-04-10
Product CodeEBD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COLORANT is the device name listed in this FDA 510(k) record. The listed applicant is Vivadent (Usa), Inc.. It received FDA 510(k) clearance on 1979-04-10 under 510(k) number K790438. The device is classified under product code EBD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLORANT?

COLORANT is a medical device that received FDA 510(k) clearance on 1979-04-10. The listed applicant is Vivadent (Usa), Inc.. The 510(k) number is K790438.

When did COLORANT receive FDA 510(k) clearance?

COLORANT received FDA 510(k) clearance on 1979-04-10, under 510(k) number K790438.

Who is the listed applicant for COLORANT?

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

What is the FDA product code for COLORANT?

The FDA product code for COLORANT is EBD.

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Other records listing Vivadent (Usa), 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: EBD)

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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