FDA UDI Not in Commercial Distribution 🇺🇸 United States

CROSS LINKED 2

DI: EPOLCL05D2 · Model: CL.05D2 · POLIDENT d.o.o.
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1

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Basic Information

Brand Name
CROSS LINKED 2
Primary DI
EPOLCL05D2
Version / Model
CL.05D2
Catalog Number
CL.05D2
Company Name
POLIDENT d.o.o.
Labeler DUNS
644778409
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-06-10
Public Version
3
Public Version Date
2024-11-28
Public Version Status
Update
Public Device Record Key
00b4a74e-e11b-429f-a727-ac2512e0f76c
Distribution End Date
2024-11-28

Device Description

Resin Artificial Teeth

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
MR Safe
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Dry Heat Sterilization

Product Codes

Code Name
ELM Denture, plastic, teeth

GMDN Terms

Code Name
17845 Partial denture
38595 Custom-made dental crown, polymer

Identifiers

Type ID
Package EPOLCL05D203
Primary EPOLCL05D2

Customer Contacts

Phone
+38653304840

Device Sizes

Type Value Unit Text
Device Size Text, specify Size text
Outer Diameter 3 Meter

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
-30 – 40 Degrees Celsius
Type
Special Storage Condition, Specify
Special Conditions
keep out of sunlight