FDA.reportPublic FDA data

3:45 MULTILAYER

Primary DI
00860001538182
Brand
3:45 MULTILAYER
Company
AMSUSA LLC
Model
UM
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
00860001538182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001538182008600015381828600015381820860001538182

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
008600015381753:45 MONOUS2026-04-07
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
EDMC32603024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32603087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32613024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32613087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32623024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32623087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32633024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32633087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32643024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32643087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32653024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32653087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32663024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32663087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32673024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32673087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32683024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32683087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32693024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32693087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32703024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32703087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32713024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32713087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32713098180NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32723024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32723087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32723098180NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32733024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32733087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16