FDA 510(k)

3M RelyX Pediatric Resin Modified Glass Ionomer Cement

K号: K191122 · 2019-05-29

决定日期2019-05-29

产品代码EMA

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决定实质等同

器械摘要

3M RelyX Pediatric Resin Modified Glass Ionomer Cement is the device name listed in this FDA 510(k) record. The listed applicant is 3M Espe Dental Products. It received FDA 510(k) clearance on 2019-05-29 under 510(k) number K191122. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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. The listed applicant is 3M Espe Dental Products. The 510(k) number is K191122.

When did 3M RelyX Pediatric Resin Modified Glass Ionomer Cement receive FDA 510(k) clearance?

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

Who is the listed applicant for 3M RelyX Pediatric Resin Modified Glass Ionomer Cement?

The FDA 510(k) record lists 3M Espe Dental Products as the applicant. This does not by itself establish the device manufacturer.

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.

列明3M Espe Dental Products为申报人的其他记录

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