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FDA 510(k)

JUMBO GLASS IONOMER CEMENT

K-Number: K980568 · 1998-04-30

ApplicantCentrix, Inc.
Decision Date1998-04-30
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

JUMBO GLASS IONOMER CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Centrix, Inc.. It received FDA 510(k) clearance on 1998-04-30 under 510(k) number K980568. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JUMBO GLASS IONOMER CEMENT?

JUMBO GLASS IONOMER CEMENT is a medical device that received FDA 510(k) clearance on 1998-04-30. The listed applicant is Centrix, Inc.. The 510(k) number is K980568.

When did JUMBO GLASS IONOMER CEMENT receive FDA 510(k) clearance?

JUMBO GLASS IONOMER CEMENT received FDA 510(k) clearance on 1998-04-30, under 510(k) number K980568.

Who is the listed applicant for JUMBO GLASS IONOMER CEMENT?

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

What is the FDA product code for JUMBO GLASS IONOMER CEMENT?

The FDA product code for JUMBO GLASS IONOMER CEMENT is EMA.

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Related Devices (Code: EMA)

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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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