K-number	K052097
Device name	CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE
Applicant	Dentsply International
Product code	EBF
Device class	Class II
Decision date	Aug 12, 2005
Decision	Substantially Equivalent
Regulation	872.3690

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View the full FDA submission: accessdata.fda.gov

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CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE

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