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FDA 510(k)

ALGINMAX, ORTHOCHROME

K-Number: K963205 · 1996-10-29

ApplicantAmerican Tooth Industries
Decision Date1996-10-29
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALGINMAX, ORTHOCHROME is the device name listed in this FDA 510(k) record. The listed applicant is American Tooth Industries. It received FDA 510(k) clearance on 1996-10-29 under 510(k) number K963205. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALGINMAX, ORTHOCHROME?

ALGINMAX, ORTHOCHROME is a medical device that received FDA 510(k) clearance on 1996-10-29. The listed applicant is American Tooth Industries. The 510(k) number is K963205.

When did ALGINMAX, ORTHOCHROME receive FDA 510(k) clearance?

ALGINMAX, ORTHOCHROME received FDA 510(k) clearance on 1996-10-29, under 510(k) number K963205.

Who is the listed applicant for ALGINMAX, ORTHOCHROME?

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

What is the FDA product code for ALGINMAX, ORTHOCHROME?

The FDA product code for ALGINMAX, ORTHOCHROME is ELW.

Related Clinical Trials

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: ELW)

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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