K-number	K252073
Device name	VOCO Profluorid Varnish + BioMin
Applicant	Voco GmbH
Product code	LBH
Device class	Class II
Decision date	May 1, 2026
Decision	Substantially Equivalent
Regulation	872.3260

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

VOCO Profluorid Varnish + BioMin is a cavity varnish indicated for treating hypersensitive teeth and sealing dentinal tubules for cavity preparations or on sensitive root surfaces. It is a prescription-use dental device classified as Class II.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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VOCO Profluorid Varnish + BioMin

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