Home / 510(k) Clearances / K192412

510(k) K192412

SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece by Dentalez, Inc. — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2020
Date Received
September 4, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Air-Powered, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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  • K093072 — STARCARE HANDPIECE MAINTENANCE UNIT (December 28, 2009)
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