K-number	K250222
Device name	SDF Pro
Applicant	Belport Company, Inc., Gingi-Pak
Product code	PHR
Device class	Class II
Decision date	May 7, 2025
Decision	Substantially Equivalent
Regulation	872.3260

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

SDF Pro is a cavity varnish dental device intended for use by dental professionals to treat tooth hypersensitivity in adults over age 21. It is classified as a Class II medical device under regulation 21 CFR 872.3260 and is for prescription use.

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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SDF Pro

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