FDA.reportPublic FDA data

PMMA CAD/CAM disc

Primary DI
EPOLPMFLAG5600
Brand
PMMA CAD/CAM disc
Company
POLIDENT d.o.o.
Model
PMFLAG.560
Catalog number
PMFLAG.560
Device description
PMMA CAD/CAM disc DE FLAG-20-98,5-SHOULDER
Published
2025-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBGCrown And Bridge, Temporary, Resin
ELMDenture, Plastic, Teeth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2
ELMDenture, Plastic, TeethDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EPOLPMFLAG5600PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Resin artificial teethPrefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+38653304840polident@polident.si

Regulatory Flags#

DUNS number
644778409
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EPOLPMMP484Pink CAD/CAM DiscPMMP.484PMMP.4842021-06-15
EPOLPMMP485Pink CAD/CAM DiscPMMP.485PMMP.4852021-06-15
EPOLPMMP486Pink CAD/CAM DiscPMMP.486PMMP.4862021-06-15
EPOLPMMP487Pink CAD/CAM DiscPMMP.487PMMP.4872021-06-15
EPOLPMMPML10300Pink CAD/CAM DiscPMMPML.1030PMMPML.10302025-12-05
EPOLPMMPML10310Pink CAD/CAM DiscPMMPML.1031PMMPML.10312025-12-05
EPOLPMMPML10320Pink CAD/CAM DiscPMMPML.1032PMMPML.10322025-12-05
EPOLPMMPML10330Pink CAD/CAM DiscPMMPML.1033PMMPML.10332025-12-05
EPOLPMMPML10340Pink CAD/CAM DiscPMMPML.1034PMMPML.10342025-12-05
EPOLPMMPML10350Pink CAD/CAM DiscPMMPML.1035PMMPML.10352025-12-05
EPOLPMMPML10360Pink CAD/CAM DiscPMMPML.1036PMMPML.10362025-12-05
EPOLPMMPML10370Pink CAD/CAM DiscPMMPML.1037PMMPML.10372025-12-05
EPOLPMMPML10380Pink CAD/CAM DiscPMMPML.1038PMMPML.10382025-12-05
EPOLPMMPML10390Pink CAD/CAM DiscPMMPML.1039PMMPML.10392025-12-05
EPOLPMMPML10400Pink CAD/CAM DiscPMMPML.1040PMMPML.10402025-12-05
EPOLPMMPML10410Pink CAD/CAM DiscPMMPML.1041PMMPML.10412025-12-05
EPOLPMMPML10420Pink CAD/CAM DiscPMMPML.1042PMMPML.10422025-12-05
EPOLPMMPML10430Pink CAD/CAM DiscPMMPML.1043PMMPML.10432025-12-05
EPOLPMMPML10440Pink CAD/CAM DiscPMMPML.1044PMMPML.10442025-12-05
EPOLPMMPML10450Pink CAD/CAM DiscPMMPML.1045PMMPML.10452025-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942201762285FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201762377FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201762476FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774288FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774387FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774479FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774578FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774769FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774950FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774967FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774981FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775056FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775155FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775179FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775230FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775247FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775339FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775346FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775438FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775537FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775728FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
D0804SNEAZ107ULXD30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ129ULA350NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ129ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ129ULXA30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ129ULXB20NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ129ULXB30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ129ULXD30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ144ULW050NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ144ULXA10NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25