Search Results
Found 2 results
510(k) Data Aggregation
K Number
K143071Device Name
Nacera Pearl
Manufacturer
DOCERAM MEDICAL CERAMICS GMBH
Date Cleared
2015-06-26
(242 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
DOCERAM MEDICAL CERAMICS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nacera Pearl blanks are indicated for the fabrication of single crowns and bridgework:
- > fully anatomical single crowns and bridgework (FCZ)
- > Partially veneered or fully veneered crowns and bridges
- > Inlays, onlays, and Maryland bridges
- > Primary telescopic crowns
for anterior and posterior applications
Device Description
The devices covered by this submission are milling blanks for the fabrication of custom-made all-ceramic dental restoration. The devices are manufactured from yttria-stabilized tetragonal zirconia (Y-TZP) complying with all applicable requirements of ISO 6872 (dental ceramics) and all requirements of ISO 13356 (ceramic materials for implants for surgery). They are provided in a partially sintered (pre-sintered) state. They are intended to be used by dental professionals e.g. dental technicians, for the fabrication of custom-made restorations for the sole use of a particular patient. These restorations are designed virtually by dental technicians using the CAD technology on the basis of intraoral scans or scans from impressions and/or models. The designed restorations are to be machined in all appropriate CAM Milling Centers out of Nacera Pearl blanks and finally sintered to full density. On basis of the available shades the finished restorations, sintered to full density, may be used as full-contour, all-ceramic prosthesis or may be veneered with suitable dental porcelains using the layering technique. Telescopic primary crowns will not be veneered. Nacera Pearl blanks are available in various shapes and dimensions such as discs, cylinders, bars, cubes, or other required forms, in order to meet the specifications of the different CAD/CAM milling machines used to generate the desired dental restorations. Nacera Pearl blanks are available in various shades in order to correspond to the different natural teeth colors and have a closer appearance to a natural tooth.
Ask a Question
K Number
K080195Device Name
NACERA Z AND NACERA Z MEDIUM
Manufacturer
DOCERAM MEDICAL CERAMICS GMBH
Date Cleared
2008-04-28
(94 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
DOCERAM MEDICAL CERAMICS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nacera Z and Nacera Z Medium are a dental ceramic designed to be used by dental technicians to manufacture all-ceramic restorations. Nacera Z and Nacera Z medium are Yttria (Yttrium Oxide) stabilized tetragonal zirconia (Zirconia oxide) powder delivered in a partially sintered state.
Nacera Z and Nacera Z Medium is specially designed for use as framework (substructure) for dental restorations, single tooth or bridge type application at anterior and posterior locations.
It is prepared for machining by use of CAM-techniques.
The machined frameworks like dental crown and bridge works are sintered to full density.
Device Description
Nacera Z is a ceramic material for dental restorations.
Nacera Z is composed of partially sintered yttrium oxide stabilized zirconium oxide.
Nacera Z is designed for manufacturing all-ceramic dental restorations (substructures) for the sole use of particular patients. It is machined on milling centers by use of CAD/CAM techniques for design and processing.
Nacera Z is designed for dental restorations like single tooth crowns or bridgeworks. It is biocompatible, biostable, and insoluble in water.
Due to the outstanding high strength of densely sintered ceramic restorations Nacera Z enables dental technicians to design finely shaped, precise, and filigree framework.
Nacera Z is delivered as presintered white blanks, which change during final sintering and effected by minimal alterations of oxide composition to characteristic hues from white to light pearl. That offers an outstanding basis for aesthetical restorations.
All above mentioned advantages ensure safe, resistant, and effective dental restorations.
Nacera Z substructures are well suited to be veneered with suitable dental porcelains using the layering technique.
Nacera Z meets all applicable requirements of International standard ISO 6872:1999 "Dental ceramic". It meets even the the international standard 13356:1997 "Implants for surgery -Ceramic materials based on yttria-stabilized tetragonal zirkonia" for biocompatible and biostable dental implants and restorations.
The partially sintered Nacera Z blanks are fabricated in two different types, distincted by their presintered density and hue, each type available as disks with different dimensions depending upon custormer's request.
Nacera Z is delivered in various shapes and dimensions in order to meet individual customer requirements. Possible shapes are: disk, cylinder, cube.
Nacera Z is available in two different types. Nacera Z and Nacera Z Medium. The differ in hue effected by slightly changed ratios of the oxides in order to meet individual customer's requirements. Both types are available in both presintered densities 3,09 g/cm³ and 3,20 g/cm³
Ask a Question
Page 1 of 1