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FDA 510(k)

TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT

K-Number: K030036 · 2003-03-12

ApplicantPulpdent Corporation
Decision Date2003-03-12
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corporation. It received FDA 510(k) clearance on 2003-03-12 under 510(k) number K030036. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT?

TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT is a medical device that received FDA 510(k) clearance on 2003-03-12. The listed applicant is Pulpdent Corporation. The 510(k) number is K030036.

When did TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT receive FDA 510(k) clearance?

TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT received FDA 510(k) clearance on 2003-03-12, under 510(k) number K030036.

Who is the listed applicant for TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT?

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

What is the FDA product code for TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT?

The FDA product code for TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT is DYH.

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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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