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510(k) K030133

SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE by Dentalez Group — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2003
Date Received
January 14, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

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  • K902402 — HIGH SPEED NON-FIBER OPTIC SWIVEL HANDPIECE (August 29, 1990)

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