DENTAPLAST HOT, MODEL 16-XXX (K052780) — FDA 510(k) Clearance | Predicase

K-number	K052780
Device name	DENTAPLAST HOT, MODEL 16-XXX
Applicant	Bredent-Products For the Dental Technician Laborat
Product code	EBI
Device class	Class II
Decision date	Dec 21, 2005
Decision	Substantially Equivalent
Regulation	872.3760

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 →