AccessGUDID - DEVICE: PRIMODENT (EPOLPRI46Y3)

GUDID

Device Identifier (DI) Information

Brand Name: PRIMODENT
Version or Model: PRI.46Y3
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PRI.46Y3
Company Name: POLIDENT d.o.o.

Primary DI Number: EPOLPRI46Y3
Issuing Agency: HIBCC
Commercial Distribution End Date:
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?
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
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

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: No 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: cbf1cfaf-db6c-407a-bc3a-fce25923fb70
Public Version Date: June 22, 2021
Public Version Number: 1
DI Record Publish Date: June 14, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
EPOLPRI46Y303	1	EPOLPRI46Y3	2021-06-14	Not in Commercial Distribution	plastic card

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +38653304840
Email: polident@polident.si

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES