FDA.reportPublic FDA data

PREMIOtemp

Primary DI
D831PMMONOA198X300
Brand
PREMIOtemp
Company
PRIMOTEC LLC
Model
PM-Mono-A1-98x30
Published
2018-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D831PMMONOA198X300PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental crown/bridge, temporaryA prosthetic dental device used to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
153454736
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D831PS100US1PrimosplintPS100US2021-11-09
D831PS202US0primostickPS202US2021-11-09
D831PS204US0primoglazePS204US2021-11-09
D831PSKIT1primosplint systemPSKIT12021-11-09
D831PMCLEAR95X200PREMIOtempPM-Clear-95x202018-09-10
D831PMCLEAR95X250PREMIOtempPM-Clear-95x252018-09-10
D831PMCLEAR98X100PREMIOtempPM-Clear-98x102018-09-10
D831PMCLEAR98X120PREMIOtempPM-Clear-98x122018-09-10
D831PMCLEAR98X140PREMIOtempPM-Clear-98x142018-09-10
D831PMCLEAR98X160PREMIOtempPM-Clear-98x162018-09-10
D831PMCLEAR98X180PREMIOtempPM-Clear-98x182018-09-10
D831PMCLEAR98X200PREMIOtempPM-Clear-98x202018-09-10
D831PMCLEAR98X250PREMIOtempPM-Clear-98x252018-09-10
D831PMMONOA195X200PREMIOtempPM-Mono-A1-95x202018-08-15
D831PMMONOA195X250PREMIOtempPM-Mono-A1-95x252018-08-15
D831PMMONOA198X160PREMIOtempPM-Mono-A1-98x162018-08-15
D831PMMONOA198X180PREMIOtempPM-Mono-A1-98x182018-08-15
D831PMMONOA198X200PREMIOtempPM-Mono-A1-98x202018-08-15
D831PMMONOA198X250PREMIOtempPM-Mono-A1-98x252018-08-15
D831PMMONOA295X200PREMIOtempPM-Mono-A2-95x202018-08-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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