K-number	K251470
Device name	ResiCem EX
Applicant	Shofu Dental Corporation
Product code	EMA
Device class	Class II
Decision date	Jul 11, 2025
Decision	Substantially Equivalent
Regulation	872.3275

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

ResiCem EX is a dental cement used for cementing all-ceramic, composite, and metal restorations, as well as for post cementation. It is a prescription-use device intended for professional dental applications.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

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 →

ResiCem EX

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