FDA.reportPublic FDA data

REF-LINE

Primary DI
EPOLREFQ3SC203
Brand
REF-LINE
Company
POLIDENT d.o.o.
Model
REF.Q3SC2
Catalog number
REF.Q3SC2
Device description
Resin Artificial Teeth
Published
2021-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
false

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
EPOLREFQ3SC203PackageHIBCC1Not in Commercial Distribution
EPOLREFQ3SC2PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made dental crown, polymerA device made entirely of polymer-based material with or without fibre reinforcement, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Outer Diameter3Meter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00keep out of sunlight
Storage Environment Temperature-30 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
644778409
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
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
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