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FDA 510(k)

FLOWABLE HYBRID

K-Number: K980298 · 1998-03-09

ApplicantCosmedent, Inc.
Decision Date1998-03-09
Product CodeEBD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FLOWABLE HYBRID is the device name listed in this FDA 510(k) record. The listed applicant is Cosmedent, Inc.. It received FDA 510(k) clearance on 1998-03-09 under 510(k) number K980298. The device is classified under product code EBD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLOWABLE HYBRID?

FLOWABLE HYBRID is a medical device that received FDA 510(k) clearance on 1998-03-09. The listed applicant is Cosmedent, Inc.. The 510(k) number is K980298.

When did FLOWABLE HYBRID receive FDA 510(k) clearance?

FLOWABLE HYBRID received FDA 510(k) clearance on 1998-03-09, under 510(k) number K980298.

Who is the listed applicant for FLOWABLE HYBRID?

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

What is the FDA product code for FLOWABLE HYBRID?

The FDA product code for FLOWABLE HYBRID is EBD.

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Other records listing Cosmedent, Inc. as applicant

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Related Devices (Code: EBD)

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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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