FDA.reportPublic FDA data

PREMIOtemp

Primary DI
D831PMMONOA498X180
Brand
PREMIOtemp
Company
PRIMOTEC LLC
Model
PM-Mono-A4-98x18
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
D831PMMONOA498X180PrimaryHIBCC0

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
D831PMMONOA198X300PREMIOtempPM-Mono-A1-98x302018-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942201760748FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
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06942201760960FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761035FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761134FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761158FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761219FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761226FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761325FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761417FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761424FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761516FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761707FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761714FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761806FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761899FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761998FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201762186FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
07506338322478Nic ToneMDC DENTALEBG2026-07-20
07506338322485VIVIDMDC DENTALEBG2026-07-20
07506338322492VIVIDMDC DENTALEBG2026-07-20
07506338322508VIVIDMDC DENTALEBG2026-07-20
07506338322515VIVIDMDC DENTALEBG2026-07-20
07506338322522VIVIDMDC DENTALEBG2026-07-20
07506338322539VIVIDMDC DENTALEBG2026-07-20
07506338322546VIVIDMDC DENTALEBG2026-07-20
07506338322553VIVIDMDC DENTALEBG2026-07-20
07506338322560VIVIDMDC DENTALEBG2026-07-20
07506338322577Nic Tone, MDC DentalMDC DENTALEBG2026-07-20
07506338322584Nic Tone, MDC DentalMDC DENTALEBG2026-07-20