FDA 510(k)

FLUOCAL GEL ORANGE

K-Number: K760799 · 1976-11-24

Decision Date1976-11-24

Product Code

DecisionSubstantially Equivalent

Device Summary

FLUOCAL GEL ORANGE is the device name listed in this FDA 510(k) record. The listed applicant is Septodont, Inc.. It received FDA 510(k) clearance on 1976-11-24 under 510(k) number K760799. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUOCAL GEL ORANGE?

FLUOCAL GEL ORANGE is a medical device that received FDA 510(k) clearance on 1976-11-24. The listed applicant is Septodont, Inc.. The 510(k) number is K760799.

When did FLUOCAL GEL ORANGE receive FDA 510(k) clearance?

FLUOCAL GEL ORANGE received FDA 510(k) clearance on 1976-11-24, under 510(k) number K760799.

Who is the listed applicant for FLUOCAL GEL ORANGE?

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

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Other records listing Septodont, Inc. as applicant

K780003ENDOSOLV E K771114NEUTROCIM K761355SELFAST K761354CIMPAT (PINK AND WHITE)K760798FLUOCAL GEL MINT K761024RACESTYPTINE RINGS

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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.