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FDA 510(k)

PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement

K-Number: K152652 · 2016-04-05

ApplicantGaia Dental Products, Inc.
Decision Date2016-04-05
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement is a medical device manufactured by Gaia Dental Products, Inc.. It received FDA 510(k) clearance on 2016-04-05 under approval number K152652. 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 PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement?

PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement is a medical device that received FDA 510(k) clearance on 2016-04-05. It is manufactured by Gaia Dental Products, Inc.. The 510(k) number is K152652.

When was PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement approved by the FDA?

PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement received FDA 510(k) clearance on 2016-04-05, under approval number K152652.

What company makes PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement?

PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement is manufactured by Gaia Dental Products, Inc..

What is the FDA product code for PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement?

The FDA product code for PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement is EMA.

Related Clinical Trials

NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT07261137 Efficacy of Solventum™ Vitrebond™ Pulp Protect Liner/Base Used as a Liner/Base Under Dental Restorations TERMINATED NCT07122089 Evaluation of SIRT Followed by Immunotherapy for Treatment of Hepatocellular Carcinoma With Portal Vein Thrombosis RECRUITING NCT07524842 Clinical Performance of Three Different Restorative Materials NOT_YET_RECRUITING NCT07552350 Bioactive Restorative Materials for Class II Restorations ACTIVE_NOT_RECRUITING NCT07504393 Clinical Performance of Four Restorative Materials in Primary Molars NOT_YET_RECRUITING

Related Devices (Code: EMA)

K160800DuoCemColtene/Whaledent AG K161851Glass Ionomer Cement (Luting)Shandong Huge Dental Material Corporation K160443TempoCem ClearDmg USA, Inc. K160774IonoStar PlusVoco GmbH K161256TheraCemBisco, Inc. K153231G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc.

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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