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FDA 510(k)

CHROMASCAN TM

K-Number: K770667 · 1977-04-20

ApplicantSterndent Corp.
Decision Date1977-04-20
Product CodeKZN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CHROMASCAN TM is the device name listed in this FDA 510(k) record. The listed applicant is Sterndent Corp.. It received FDA 510(k) clearance on 1977-04-20 under 510(k) number K770667. The device is classified under product code KZN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHROMASCAN TM?

CHROMASCAN TM is a medical device that received FDA 510(k) clearance on 1977-04-20. The listed applicant is Sterndent Corp.. The 510(k) number is K770667.

When did CHROMASCAN TM receive FDA 510(k) clearance?

CHROMASCAN TM received FDA 510(k) clearance on 1977-04-20, under 510(k) number K770667.

Who is the listed applicant for CHROMASCAN TM?

The FDA 510(k) record lists Sterndent Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHROMASCAN TM?

The FDA product code for CHROMASCAN TM is KZN.

Related Clinical Trials

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Other records listing Sterndent Corp. 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.

K771128NEKO CERAMIC CONVENIENCE CROWNS

Related Devices (Code: KZN)

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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