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FDA 510(k)

ADVANCED GLASS IONOMER (K-130) RESTORATIVE

K-Number: K101493 · 2010-08-19

ApplicantDentsply International, Inc.
Decision Date2010-08-19
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ADVANCED GLASS IONOMER (K-130) RESTORATIVE is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply International, Inc.. It received FDA 510(k) clearance on 2010-08-19 under 510(k) number K101493. 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 ADVANCED GLASS IONOMER (K-130) RESTORATIVE?

ADVANCED GLASS IONOMER (K-130) RESTORATIVE is a medical device that received FDA 510(k) clearance on 2010-08-19. The listed applicant is Dentsply International, Inc.. The 510(k) number is K101493.

When did ADVANCED GLASS IONOMER (K-130) RESTORATIVE receive FDA 510(k) clearance?

ADVANCED GLASS IONOMER (K-130) RESTORATIVE received FDA 510(k) clearance on 2010-08-19, under 510(k) number K101493.

Who is the listed applicant for ADVANCED GLASS IONOMER (K-130) RESTORATIVE?

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

What is the FDA product code for ADVANCED GLASS IONOMER (K-130) RESTORATIVE?

The FDA product code for ADVANCED GLASS IONOMER (K-130) RESTORATIVE 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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