Name: Predicase
Price: 199 USD

K-number	K251129
Device name	S.I.N. Tapered Pro Conical Zygoma Implant System
Applicant	S.I.N. Implant System Ltda
Product code	DZE
Device class	Class II
Decision date	Nov 7, 2025
Decision	Substantially Equivalent
Regulation	872.3640

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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S.I.N. Tapered Pro Conical Zygoma Implant System

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