SUMO GLASS IONOMER CEMENT— 510(k) K913519

Substantially Equivalent

Ortho Source

FDA 510(k) clearance K913519 for SUMO GLASS IONOMER CEMENT, Substantially Equivalent on 1991-11-19. Applicant: Ortho Source. Device class: 2.

Clearance details

Applicant
Ortho Source
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
North Hollywood, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.