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510(k) Data Aggregation
K Number
K112044Device Name
ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A
Manufacturer
Date Cleared
2012-01-26
(192 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
ANAXDENT GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
anaxBLEND:
- full or partial facing of fixed metal-based crowns and bridges;
- anterior and posterior crowns;
- inlays, onlays;
- facing of removable combined restorations (telescopic/conical crowns and attachment retained dentures);
- Characterization of dentures
anaxGUM:
- Esthetic rehabilitation of gingival parts in case of dental restorations with severe bone loss;
- Facing of the gingival area of removable combined restorations (telescopic/conical crowns and attachment-retained dentures);
- Characterization of dentures
mock-up direct / mock-up direct flow:
- mock-ups;
- direct anterior and posterior fillings of the classes 1, 11, 111, and V (Black);
- indirect restorations as inlays, onlays and veneers;
- extended fissure sealing of molars and premolars;
- core build-ups;
- splinting of loose teeth;
- shape and color corrections to improve the esthetic appearance
Device Description
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K Number
K023079Device Name
NEW OUTLINE
Manufacturer
Date Cleared
2002-10-30
(44 days)
Product Code
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
ANAXDENT GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
NEW OUTLINE is a resin used by dentists and dental technicians to fabricate temporary crowns and bridges.
Device Description
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