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510(k) K062176

RELIEF ACP ORAL CARE GEL by Discus Dental, Inc. — Product Code LBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2007
Date Received
July 31, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Varnish, Cavity
Device Class
Class II
Regulation Number
872.3260
Review Panel
DE
Submission Type

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  • K073518 — FLASHLITE REBEL* (December 20, 2007)
  • K052090 — SPLASH! IMPRESSION MATERIAL DEVICE (August 5, 2005)
  • K051776 — PROTEGE ULTRASONIC INSERT (July 13, 2005)
  • K033785 — PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE (June 18, 2004)
  • K040053 — PRECISION VPS IMPRESSION MATERIAL (March 25, 2004)

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