Name: Predicase
Price: 199 USD

K-number	K101029
Device name	KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH
Applicant	Huge Dental Material Co., Ltd.
Product code	ELM
Device class	Class II
Decision date	Aug 16, 2010
Decision	Substantially Equivalent
Regulation	872.3590

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 →

KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH

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