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FDA 510(k)

DENTACOLOR(R) CRE-ACTIVE

K-Number: K914456 · 1992-03-11

ApplicantHeraeus Kulzer, Inc.
Decision Date1992-03-11
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTACOLOR(R) CRE-ACTIVE is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1992-03-11 under 510(k) number K914456. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTACOLOR(R) CRE-ACTIVE?

DENTACOLOR(R) CRE-ACTIVE is a medical device that received FDA 510(k) clearance on 1992-03-11. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K914456.

When did DENTACOLOR(R) CRE-ACTIVE receive FDA 510(k) clearance?

DENTACOLOR(R) CRE-ACTIVE received FDA 510(k) clearance on 1992-03-11, under 510(k) number K914456.

Who is the listed applicant for DENTACOLOR(R) CRE-ACTIVE?

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

What is the FDA product code for DENTACOLOR(R) CRE-ACTIVE?

The FDA product code for DENTACOLOR(R) CRE-ACTIVE is EBF.

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Other records listing Heraeus Kulzer, 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: EBF)

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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