FDA.reportPublic FDA data

3:45 MONO

Primary DI
00860001538175
Brand
3:45 MONO
Company
AMSUSA LLC
Model
US
Device description
Zirconia Disc
Published
2026-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00860001538175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001538175008600015381758600015381750860001538175

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
062739116
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860001538113 ECLIPSE 2.0UZ2026-04-07
00860001538151ECLIPSE Kiss PlusUZ2026-04-07
008600015381823:45 MULTILAYERUM2026-04-07
00860001538106ECLIPSE 2.0 PlusUZ2025-05-05
00860001538120ECLIPSE KissUS2025-05-05
00860001538144ECLIPSE 2.0 Plus Shade DiskUS2025-05-05
00860001538168ECLIPSE MultiUM2025-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
J011254000020ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254000100ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254000500ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254001020ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254001100ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254001500ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254002020ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254002100ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254002500ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254004020ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254004100ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254006020ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254006100ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254008020ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254008100ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254010020ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254010100ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254012020Triceram®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254014020Triceram®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254300020ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254301020ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254302020ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254303020ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254304020ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
06942629805069Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-22
06942629805298Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-22
06942629805526Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-22
06942629805755Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-22
06942629805984Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-22
06942629805090Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21