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510(k) Data Aggregation
K Number
K211854Device Name
VITA Akzent LC
Manufacturer
VITA Zahnfabrik GmbH H Rauter & Co
Date Cleared
2021-11-22
(159 days)
Product Code
EBD
Regulation Number
872.3310Why did this record match?
Applicant Name (Manufacturer) :
**VITA Zahnfabrik GmbH H Rauter **& Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VITA AKZENT LC Indication range:
- Restorations made of hybrid ceramic
- · Restorations made of light-curing veneering material
- · Restorations made of CAD/CAM composites
- · Prefabricated Teeth
- · Denture bases
Device Description
VITA AKZENT LC is a light-curing methacrylatebased stain/ glaze system for extraoral surface characterization of dental restorations made of hybrid ceramic, resin veneering materials, CAD/CAM composites, prefabricated teeth and denture base resins. It can also be used for internal characterization with the layering technique of veneering composites.
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K Number
K193434Device Name
VITA LUMEX AC
Manufacturer
VITA Zahnfabrik GmbH H Rauter & Co
Date Cleared
2020-07-21
(223 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
**VITA Zahnfabrik GmbH H Rauter **& Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VITA Lumex® AC is used to veneer the following:
- Full and partial veneering of zirconia
- Full and partial veneering of lithium disilicate
- Partial veneering of feldspar ceramic
- Reconstruction without a substructure
Materials:
- Zirconia substructures (CTE approx. 10.0 to 10.5 x 10-6 K-1)
- Glass-ceramic substructures (CTE approx. 9.0 to 10.5 x 10-6 K-1)
Device Description
VITA Lumex® AC is a natural low-fusing veneering ceramic system that is suitable for veneering all ceramic substructures. VITA LUMEX AC standard layering consists of the two Materials DENTINE and ENAMEL. The color-bearing DENTINE materials, which provide good coverage, offer the perfect precondition for the preparation of veneers with intensive shades. With this two-layer alternative, VITA offers an ideal solution for the reproduction of optimal shade results in case of thin walls. Additionally, the intensive shade effect of the DENTINE permits a more generous use of the ENAMEL materials, which create the desired translucency. The user is able to prepare a natural restoration with a lifelike appearance with only two layers. This product is provided non-sterile in glass jars in a powder form to be used in conjunction with the Vita low fusing liquid.
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K Number
K193436Device Name
VITA Ambria
Manufacturer
VITA Zahnfabrik GmbH H Rauter & Co
Date Cleared
2020-05-14
(155 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
**VITA Zahnfabrik GmbH H Rauter **& Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VITA AMBRIA are zirconia-reinforced lithium silicate press pellets for the fabrications in the press technique.
Indications
•Occlusal veneers (table tops), veneers
- •Inlays, onlays, partial crowns
- ·Crowns in the anterior and posterior areas
- ·3-unit anterior bridges up to the second premolar
- ·Single tooth restorations as implant suprastructures for anterior and posterior teeth
- ·3-unit bridges as implant suprastructures up to the second premolar
- · Single tooth mesostructures in the anterior and posterior areas
- · Abutment crowns in the anterior and posterior areas
Device Description
VITA AMBRIA are zirconia-reinforced lithium silicate press pellets for the fabrication of restorations in the press technique.
VITA Ambria comes in various shades and is packaged in a plastic case of 5 or 3 pc pellets.
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