Name: Predicase
Price: 199 USD

K-number	K191475
Device name	Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate
Applicant	Nobel Biocare AB
Product code	KCT
Device class	Class II
Decision date	Aug 29, 2019
Decision	Substantially Equivalent
Regulation	880.6850

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate

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