K-number	K251390
Device name	MTA vpt
Applicant	Voco GmbH
Product code	KIF
Device class	Class II
Decision date	Jul 3, 2025
Decision	Substantially Equivalent
Regulation	872.3820

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

MTA vpt is a root canal filling resin classified as a Class II dental device used for pulp preservation procedures. It is indicated for indirect pulp capping, direct pulp capping, and pulpotomy procedures to preserve vitality of remaining pulp tissue after removal of affected coronal pulp.

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 →

MTA vpt

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