K-number	K243911
Device name	HPR Cordless Hygiene Handpiece
Applicant	Handpiece Headquarters
Product code	EKX
Device class	Class I
Decision date	Dec 20, 2024
Decision	Substantially Equivalent
Regulation	872.4200

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The HPR Cordless Hygiene Handpiece is a cordless prophylaxis handpiece designed for dental hygiene use. It features control buttons, a battery pack, and wireless foot control, and is intended for use with disposable prophylaxis angles to perform cleaning and polishing procedures on tooth surfaces and fillings.

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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HPR Cordless Hygiene Handpiece

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