Name: Predicase
Price: 199 USD

K-number	K152652
Device name	PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement
Applicant	Gaia Dental Products, Inc.
Product code	EMA
Device class	Class II
Decision date	Apr 5, 2016
Decision	Substantially Equivalent
Regulation	872.3275

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 →

PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement

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