FDA.reportPublic FDA data

PMMA CAD/CAM disc

Primary DI
EPOLPMMA7601
Brand
PMMA CAD/CAM disc
Company
POLIDENT d.o.o.
Model
PMMA.760
Catalog number
PMMA.760
Device description
PMMA CAD/CAM disc D2-25-98,5-SHOULDER
Published
2024-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELMDenture, Plastic, Teeth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELMDenture, Plastic, TeethDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EPOLPMMA7601PackageHIBCC1In Commercial Distribution
EPOLPMMA7600PrimaryHIBCC0

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
EPOLCL01A2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01A3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01A4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01A9CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01B1CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01B2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01B3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01B4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01C1CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01C2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01C3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01C4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01D2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01D3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01D4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01L3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02A1CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02A2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02A3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02A4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02A9CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02B1CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02B2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02B3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02B4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02C1CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02C2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02C3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02C4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02D2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10