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510(k) Data Aggregation
K Number
K142987Device Name
DD Bio Z, DD Bio ZX(square), DD BioZX(square) color
Manufacturer
DENTAL DIREKT OF AMERIKA UG (HAFTUNGSBESCHRAENKT)
Date Cleared
2015-02-11
(118 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
DENTAL DIREKT OF AMERIKA UG (HAFTUNGSBESCHRAENKT)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DD Bio Z-dental blanks are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges.
Device Description
Dental milling blanks made of DD Bio Z, DD Bio ZX 2 , DD Bio ZX 2 color are semi-finished products out of yttrium-stabilized, pre-sintered zirconium dioxide for the fabrication of crown- and bridge- frameworks on commercial CAD/CAM systems or hand-operated copy-milling machines, with outstanding biocompatibility and mechanical properties.
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K Number
K093748Device Name
DD BIO Z AND DD BIO Z - TRANSPA
Manufacturer
DENTAL DIREKT OF AMERIKA UG (HAFTUNGSBESCHRAENKT)
Date Cleared
2010-02-24
(82 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
DENTAL DIREKT OF AMERIKA UG (HAFTUNGSBESCHRAENKT)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dental Blanks made from DD Bio Z or DD Bio Z-transpa are indicated for crowns, multiunit bridges and inlay bridges. Applications include both anterior and posterior ridges.
Device Description
Dental Blanks made of DD Bio Z or DD Bio Z-transpa are dental materials (semifinished products) made of yttrium stabilized, presintered zirconium dioxide for milled production of crowns and bridges frameworks on commercial CAD/CAM systems or handoperated copy-milling machines. machines with outstanding biocompatibility and high resistance against tension and pressure.
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