Name: Predicase
Price: 199 USD

K-number	K212259
Device name	Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Applicant	Zirdent New Material Co., Ltd.
Product code	EIH
Device class	Class II
Decision date	Nov 12, 2021
Decision	Substantially Equivalent
Regulation	872.6660

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 →

Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

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