Name: Predicase
Price: 199 USD

K-number	K152959
Device name	Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes
Applicant	Sybron Dental Specialties
Product code	KIF
Device class	Class II
Decision date	Apr 14, 2016
Decision	Substantially Equivalent
Regulation	872.3820

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes

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