Name: Predicase
Price: 199 USD

K-number	K191222
Device name	Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV
Applicant	Prismatik Dentalcraft, Inc.
Product code	NHA
Device class	Class II
Decision date	Aug 5, 2019
Decision	Substantially Equivalent
Regulation	872.3630

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Source

View the full FDA submission: accessdata.fda.gov

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Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV

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