3M RelyX Pediatric Resin Modified Glass Ionomer Cement— 510(k) K191122

Substantially Equivalent

3M Espe Dental Products

FDA 510(k) clearance K191122 for 3M RelyX Pediatric Resin Modified Glass Ionomer Cement, Substantially Equivalent on 2019-05-29. Applicant: 3M Espe Dental Products. Device class: 2.

Clearance details

Applicant
3M Espe Dental Products
Product code
Code EMA
Device class
Class 2
Regulation
21 CFR 872.3275
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Saint Paul, MN, US
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