Name: Predicase
Price: 199 USD

K-number	K162536
Device name	GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord
Applicant	Kerr Corporation
Product code	MVL
Device class	Class U
Decision date	Feb 3, 2017
Decision	Substantially Equivalent
Regulation	—

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord

Everything you need for a 510(k) submission. Nothing you don't.