K-number	K251578
Device name	BEAUTIFIL II
Applicant	Shofu Dental Corporation
Product code	EBF
Device class	Class II
Decision date	May 27, 2025
Decision	Substantially Equivalent
Regulation	872.3690

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

Beautifil II is a tooth shade resin material used for anterior and posterior dental restorations, repair of existing restorations and prostheses, core buildup, and direct laminate veneer applications. It is a prescription-use dental device classified as a Class II medical device.

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

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BEAUTIFIL II

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