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FDA 510(k)

JUMBO SILVER-REINFORCED GLASS IONOMER

K-Number: K982665 · 1998-09-08

ApplicantCentrix, Inc.
Decision Date1998-09-08
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

JUMBO SILVER-REINFORCED GLASS IONOMER is the device name listed in this FDA 510(k) record. The listed applicant is Centrix, Inc.. It received FDA 510(k) clearance on 1998-09-08 under 510(k) number K982665. 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 SILVER-REINFORCED GLASS IONOMER?

JUMBO SILVER-REINFORCED GLASS IONOMER is a medical device that received FDA 510(k) clearance on 1998-09-08. The listed applicant is Centrix, Inc.. The 510(k) number is K982665.

When did JUMBO SILVER-REINFORCED GLASS IONOMER receive FDA 510(k) clearance?

JUMBO SILVER-REINFORCED GLASS IONOMER received FDA 510(k) clearance on 1998-09-08, under 510(k) number K982665.

Who is the listed applicant for JUMBO SILVER-REINFORCED GLASS IONOMER?

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 SILVER-REINFORCED GLASS IONOMER?

The FDA product code for JUMBO SILVER-REINFORCED GLASS IONOMER is 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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