Name: Predicase
Price: 199 USD

K-number	K142987
Device name	DD Bio Z, DD Bio ZX(square), DD BioZX(square) color
Applicant	Dental Direkt of Amerika UG (Haftungsbeschraenkt)
Product code	EIH
Device class	Class II
Decision date	Feb 11, 2015
Decision	Substantially Equivalent
Regulation	872.6660

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Source

View the full FDA submission: accessdata.fda.gov

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DD Bio Z, DD Bio ZX(square), DD BioZX(square) color

Everything you need for a 510(k) submission. Nothing you don't.