K-number	K121093
Device name	D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000
Applicant	Dxm Co., Ltd.
Product code	EBZ
Device class	Class II
Decision date	Nov 27, 2012
Decision	Substantially Equivalent
Regulation	872.6070

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 →

Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →

D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000

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