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510(k) K052543

HERACERAM ZIRKONIA by Heraeus Kulzer, Inc. — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2005
Date Received
September 15, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powder, Porcelain
Device Class
Class II
Regulation Number
872.6660
Review Panel
DE
Submission Type

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  • K093575 — GLUMA DESENSITIZER POWER GEL (March 5, 2010)

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