AccessGUDID - DEVICE: IDODENTINE (08435288443522)

GUDID

Device Identifier (DI) Information

Brand Name: IDODENTINE
Version or Model: DISC PINK 95/16mm
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4252Z/P
Company Name: UNION DENTAL SA

Primary DI Number: 08435288443522
Issuing Agency: GS1
Commercial Distribution End Date: December 27, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 462114760 *Terms of Use

Device Description: IDODENTINE DISC PINK 95/16mm

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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):	Yes
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?
31783	Temporary dental crown/bridge	A prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBG	Crown And Bridge, Temporary, Resin
EBI	Resin, Denture, Relining, Repairing, Rebasing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150432	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f54dd11b-5b1d-4b77-b326-5a904e678743
Public Version Date: December 28, 2023
Public Version Number: 5
DI Record Publish Date: March 10, 2017