SprintRay High Impact Denture Base

Resin, Denture, Relining, Repairing, Rebasing

SprintRay Inc.

The following data is part of a premarket notification filed by Sprintray Inc. with the FDA for Sprintray High Impact Denture Base.

Pre-market Notification Details

Device IDK221678
510k NumberK221678
Device Name:SprintRay High Impact Denture Base
ClassificationResin, Denture, Relining, Repairing, Rebasing
Applicant SprintRay Inc. 2705 Media Center Drive, Suite 100A Los Angeles,  CA  90065
ContactSara Moghtadernejad
CorrespondentSara Moghtadernejad
SprintRay Inc. 2705 Media Center Drive, Suite 100A Los Angeles,  CA  90065
Product CodeEBI  
CFR Regulation Number872.3760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-09
Decision Date2022-11-10

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