FDA.reportPublic FDA data

PIXELSTONE™

Primary DI
00810222551316
Brand
PIXELSTONE™
Company
DIGITAL ARCHES INC.
Model
OM3 / 25mm
Catalog number
ZR-PXLSTOM3-25M
Device description
Pre-sintered 8-layer polychromatic zirconia milling blank, Shade OM3, 25mm thickness, 98mm diameter. Multilayer construction with 3Y, 4Y, and 5Y zirconia providing a cervical-to-incisal strength range of 700-1200 MPa and translucency range of 43-57%. Intended for CAD/CAM milling of full-arch implant-supported zirconia prostheses followed by sintering per manufacturer specifications.
Published
2026-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810222551316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810222551316008102225513168102225513160810222551316

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Regulatory Flags#

DUNS number
145248707
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810222550043ARCHTRACER™23mm2026-04-30
00810222550050ARCHTRACER™33mmAT-DRVR33MM2026-04-30
00810222550081ARCHTRACER™28mmAT-PLDR28MM2026-04-30
00810222550098ARCHTRACER™38mmAT-PLDR38MM2026-04-30
00810222550302OPTISPLINT®LargeOS-FRAMELG-012026-04-30
00810222550333OPTISPLINT®SmallOS-FRAMESM-012026-04-30
00810222550371OPTISPLINT®1.20mm/0.048in HexOS-SCNBDY120-012026-04-30
00810222550418OPTISPLINT®1.27mm/0.050 HexOS-SCNBDY127-012026-04-30
00810222550456OPTISPLINT®M1.6 thread w/HexOS-SCNBDYM16-012026-04-30
00810222550494OPTISPLINT®Nobel Biocare UnigripOS-SCNBDYNBL-012026-04-30
00810222550531OPTISPLINT®Neodent NEOOS-SCNBDYNEO-012026-04-30
00810222550579OPTISPLINT®Strauman SCSOS-SCNBDYSTM-012026-04-30
00810222550616OPTISPLINT®Pack of 6OS-SCNCAPANA-012026-04-30
00810222550647OPTISPLINT®1.20mm/0.048in HexOS-SCNCAPMUA120-012026-04-30
00810222550678OPTISPLINT®1.27mm/0.050in HexOS-SCNCAPMUA127-012026-04-30
00810222550708OPTISPLINT®Nobel Biocare UnigripOS-SCNCAPMUANBL-012026-04-30
00810222550739OPTISPLINT®Neodent NEOOS-SCNCAPMUANEO-012026-04-30
00810222550760OPTISPLINT®Straumann SCSOS-SCNCAPMUASTR-012026-04-30
00810222551156OPTIWELD™N/AOS-WELDER5CC2026-04-29
00810222551248PIXELSTONE™A1 / 20mmZR-PXLSTA1-20M2026-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942629805106Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
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06942629805120Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805137Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805144Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805151Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
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06942629805175Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
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06942629805250Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
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06942629809012Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809029Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809036Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809043Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809074Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809098Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809104Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809111Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809128Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809135Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629808732Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-29
06942629808749Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-29
06942629808756Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-29
06942629808763Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-29
06942629808770Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-29