Name: Predicase
Price: 199 USD

K-number	K192412
Device name	SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece
Applicant	Dentalez, Inc.
Product code	EFB
Device class	Class I
Decision date	Jan 6, 2020
Decision	Substantially Equivalent
Regulation	872.4200

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece

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