AccessGUDID - DEVICE: REF-LINE (EPOLREFN6L1)

GUDID

Device Identifier (DI) Information

Brand Name: REF-LINE
Version or Model: REF.N6L1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: REF.N6L1
Company Name: POLIDENT d.o.o.

Primary DI Number: EPOLREFN6L1
Issuing Agency: HIBCC
Commercial Distribution End Date: December 19, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 644778409 *Terms of Use

Device Description: Resin Artificial Teeth

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
17845	Partial denture	A 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).	Active	false
38595	Custom-made dental crown, polymer	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ELM	Denture, plastic, teeth

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Dry Heat Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: keep out of sunlight
Storage Environment Temperature: between -30 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 3 Meter
Device Size Text, specify: Size text

Device Record Status

Public Device Record Key: bd3b1f53-bb50-4c80-8519-4df49d8fec03
Public Version Date: December 19, 2024
Public Version Number: 3
DI Record Publish Date: June 15, 2021