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FDA 510(k)

3M RelyX Pediatric Resin Modified Glass Ionomer Cement

K-Number: K191122 · 2019-05-29

Applicant3M Espe Dental Products
Decision Date2019-05-29
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

3M RelyX Pediatric Resin Modified Glass Ionomer Cement is a medical device manufactured by 3M Espe Dental Products. It received FDA 510(k) clearance on 2019-05-29 under approval number K191122. 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 3M RelyX Pediatric Resin Modified Glass Ionomer Cement?

3M RelyX Pediatric Resin Modified Glass Ionomer Cement is a medical device that received FDA 510(k) clearance on 2019-05-29. It is manufactured by 3M Espe Dental Products. The 510(k) number is K191122.

When was 3M RelyX Pediatric Resin Modified Glass Ionomer Cement approved by the FDA?

3M RelyX Pediatric Resin Modified Glass Ionomer Cement received FDA 510(k) clearance on 2019-05-29, under approval number K191122.

What company makes 3M RelyX Pediatric Resin Modified Glass Ionomer Cement?

3M RelyX Pediatric Resin Modified Glass Ionomer Cement is manufactured by 3M Espe Dental Products.

What is the FDA product code for 3M RelyX Pediatric Resin Modified Glass Ionomer Cement?

The FDA product code for 3M RelyX Pediatric Resin Modified Glass Ionomer Cement is EMA.

Related Clinical Trials

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Other Devices by 3M Espe Dental Products

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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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