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510(k) K052040

QUICKSMILE by Cosmetic Dental Materials, Inc. — Product Code EEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2005
Date Received
July 28, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Heat Source For Bleaching Teeth
Device Class
Class I
Regulation Number
872.6475
Review Panel
DE
Submission Type

Other clearances by Cosmetic Dental Materials, Inc.

  • K063626 — DURAFLEX (February 8, 2007)

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  • K895174 — UNION BROACH BLEACHING LIGHT (April 13, 1990)
  • K884937 — BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING (April 14, 1989)
  • K862385 — SCHEIN BLEACHING UNIT (October 30, 1986)
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