Name: Predicase
Price: 199 USD

K-number	K251938
Device name	GEN5 and GEN5+ Dental Implant System
Applicant	Paragon Implant Mfg., LLC
Product code	DZE
Device class	Class II
Decision date	Oct 30, 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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GEN5 and GEN5+ Dental Implant System

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