Search Results
Found 3 results
510(k) Data Aggregation
K Number
K191836Device Name
Ceramill A-Splint
Manufacturer
Amann Girrbach AG
Date Cleared
2019-12-20
(164 days)
Product Code
MQC
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Amann Girrbach AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ceramill A-Splint is indicated for the fabrication of removable bite splints.
Device Description
Ceramill A-Splint are ready to use, polymethyl methacrylate (PMMA) based computer-aided design/computer-aided manufacturing (CAD-CAM) blanks, for milling splints. Ceramill A-Splint is available as a disk (round form) or as an arch-form (or "U"-shape).
Ask a Question
K Number
K191843Device Name
Ceramill A-Temp
Manufacturer
Amann Girrbach AG
Date Cleared
2019-10-04
(87 days)
Product Code
EBG, POW
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
Amann Girrbach AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Temporary anterior and posterior crowns with a wearing time of maximum three years
- Temporary anterior and posterior bridges with a maximum of two connected pontics and a maximum wearing time of three years
- Verifying the fit on the plaster model/mouth before the final restoration
Device Description
Ceramill A-Temp are ready to use, polymethyl methacrylate (PMMA) based computeraided manufacturing (CADCAM) blanks, for milling long-term temporary crowns and bridges and for verifying the fit on the plaster model/mouth before the final restoration is manufactured.
Ceramill A-Temp is available as a disk (round form) or as an arch-form (or "U"-shape) disk or as block shape blanks.
Ask a Question
K Number
K171876Device Name
Ceramill Zolid HT+ white
Manufacturer
Amann Girrbach AG
Date Cleared
2017-09-20
(89 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
Amann Girrbach AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Zirconium-oxide blanks for permanent and removable dental prosthetics.
Device Description
Amann Girrbach AG Ceramill® Zolid HT+ white is an all-ceramic core dental material made of Yttria-Stabilized Zirconium Oxide (zirconia, YSZ). It is provided as a disk shape (U-shape or round-shape). CAD/CAM fabrication of core material can then be used to produce copings and substrates for fixed all ceramic dental restorations above the gum line. The material is used for the manufacturing of permanent and removable prosthetic restorations. The material is then fired in an oven to harden the ZrO2. The milling and final oven hardening is completed by the customer (the dental technician).
Ask a Question
Page 1 of 1