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FDA 510(k)

COLTENE ORALLOY MAGICAPS

K-Number: K840297 · 1984-03-16

ApplicantColtene, Inc.
Decision Date1984-03-16
Product CodeEJJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COLTENE ORALLOY MAGICAPS is the device name listed in this FDA 510(k) record. The listed applicant is Coltene, Inc.. It received FDA 510(k) clearance on 1984-03-16 under 510(k) number K840297. The device is classified under product code EJJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLTENE ORALLOY MAGICAPS?

COLTENE ORALLOY MAGICAPS is a medical device that received FDA 510(k) clearance on 1984-03-16. The listed applicant is Coltene, Inc.. The 510(k) number is K840297.

When did COLTENE ORALLOY MAGICAPS receive FDA 510(k) clearance?

COLTENE ORALLOY MAGICAPS received FDA 510(k) clearance on 1984-03-16, under 510(k) number K840297.

Who is the listed applicant for COLTENE ORALLOY MAGICAPS?

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

What is the FDA product code for COLTENE ORALLOY MAGICAPS?

The FDA product code for COLTENE ORALLOY MAGICAPS is EJJ.

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Other records listing Coltene, Inc. as applicant

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K902392COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIALK882800COLTENE PRESIDENT JET REGULAR BODYK873671COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEMK870266COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEMK870047COLTENE RAPIDK863998COLTENE JET-MIXER

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Related Devices (Code: EJJ)

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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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