Name: Predicase
Price: 199 USD

K-number	K201225
Device name	Neodent Implant System - GM Helix Implants 7.0
Applicant	Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Product code	DZE
Device class	Class II
Decision date	Sep 4, 2020
Decision	Substantially Equivalent
Regulation	872.3640

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

Neodent Implant System - GM Helix Implants 7.0

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