FDA.reportPublic FDA data

CROSS LINKED 2

Primary DI
EPOLCL05D4
Brand
CROSS LINKED 2
Company
POLIDENT d.o.o.
Model
CL.05D4
Catalog number
CL.05D4
Device description
Resin Artificial Teeth
Published
2021-06-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe

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
EPOLCL05D403PackageHIBCC1Not in Commercial Distribution
EPOLCL05D4PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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#

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
Premarket exempt
true
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
00810222900046Midas Restore - C2 - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00810222900053Midas Restore - C2 - Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
00850070544610Midas Restore - A1 - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00850070544627Midas Restore - A2 - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00850070544634Midas Restore - A3 - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00850070544641Midas Restore - B1 - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00850070544658Midas Restore - Bleach - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00850070544665Midas Restore - Unpigmented - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00850070544672Midas Restore - A1 - Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
00850070544689Midas Restore - A2 - Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
00850070544696Midas Restore - A3 - Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
00850070544702Midas Restore - B1 - Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
00850070544719Midas Restore - Bleach - Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
00850070544726Midas Restore - Unpigmented- Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
07630813462639TCR MultiCandulor AGELM2026-07-28
07630813462646TCR MultiCandulor AGELM2026-07-28
07630813462653TCR MultiCandulor AGELM2026-07-28
07630813462660TCR MultiCandulor AGELM2026-07-28
07630813462677TCR MultiCandulor AGELM2026-07-28
07615208592634Ivotion DentIVOCLAR VIVADENT AKTIENGESELLSCHAFTELM2026-07-09
07615208592689Ivotion DentIVOCLAR VIVADENT AKTIENGESELLSCHAFTELM2026-07-09
07615208592696Ivotion DentIVOCLAR VIVADENT AKTIENGESELLSCHAFTELM2026-07-09
07615208592702Ivotion DentIVOCLAR VIVADENT AKTIENGESELLSCHAFTELM2026-07-09
07615208592719Ivotion DentIVOCLAR VIVADENT AKTIENGESELLSCHAFTELM2026-07-09
E235DPCS0DentaprintSHOFU DENTAL CORPORATIONELM2026-06-23
E235DPMS0DentaprintSHOFU DENTAL CORPORATIONELM2026-06-23
E235DPOMS0DentaprintSHOFU DENTAL CORPORATIONELM2026-06-23
E235DPSGS0DentaprintSHOFU DENTAL CORPORATIONELM2026-06-23
E235DPTIS0DentaprintSHOFU DENTAL CORPORATIONELM2026-06-23
EGEB290040TRIBOS 501 C Composite teeth SLA-UJ-3,5Gebdi Dental-Products GmbHELM2026-06-03