K-number	K152243
Device name	One Coat 7 Universal
Applicant	Coltene/Whaledent AG
Product code	KLE
Device class	Class II
Decision date	Dec 9, 2015
Decision	Substantially Equivalent
Regulation	872.3200

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 →

One Coat 7 Universal

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