FDA.report

PRIMODENT

Primary DI
EPOLPRII5Y603
Brand
PRIMODENT
Company
POLIDENT d.o.o.
Model
PRI.I5Y6
Catalog number
PRI.I5Y6
Device description
Resin Artificial Teeth
Published
2021-06-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ELMDenture, plastic, teeth

Product Code Classifications

CodeDeviceSpecialtyClass
ELMDenture, Plastic, TeethDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EPOLPRII5Y603PackageHIBCC1Not in Commercial Distribution
EPOLPRII5Y6PrimaryHIBCC0

GMDN Terms

TermDefinition
Partial dentureA custom-made, removeable, artificial replacement for one or more, but not all, teeth in the lower or upper jaw (mandible or maxilla) in a partially edentulous patient. It typically includes clasps of metal or plastic that clip onto remaining teeth for retention and stabilization. It can be made of a variety of materials including polymers [polymethylmethacrylate (PMMA), polycarbonate (PC)], acrylic, ceramics, and/or metals [e.g., base metal alloys or titanium (Ti)]. Also known as a removable partial denture (RPD).

Device Sizes

TypeValueUnit
Device Size Text, specify0
Outer Diameter3Meter

Storage And Handling

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

Sterilization Methods

Method
Dry Heat Sterilization

Contacts

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
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 DIBrandModelCatalogPublished
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
EPOLPMMPML10460Pink CAD/CAM DiscPMMPML.1046PMMPML.10462025-12-05
EPOLPMMPML10470Pink CAD/CAM DiscPMMPML.1047PMMPML.10472025-12-05
EPOLPMMPML10480Pink CAD/CAM DiscPMMPML.1048PMMPML.10482025-12-05
EPOLPMMPML10490Pink CAD/CAM DiscPMMPML.1049PMMPML.10492025-12-05

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