AccessGUDID - DEVICE: ORTOLUX TOP (08435288432885)

GUDID

Device Identifier (DI) Information

Brand Name: ORTOLUX TOP
Version or Model: ANTERIOR TEETH B4/226
Commercial Distribution Status: In Commercial Distribution
Catalog Number: D3B4226
Company Name: UNION DENTAL SA

Primary DI Number: 08435288432885
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 462114760 *Terms of Use

Device Description: ORTOLUX TOP anterior Teeth Shade B4, Mould 226

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:	Yes
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?
38643	Resin artificial teeth	Prefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ELM	Denture, Plastic, Teeth

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K070591	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: 64feacf2-9e68-4a0d-923a-d9760f4c06f4
Public Version Date: September 26, 2024
Public Version Number: 1
DI Record Publish Date: September 18, 2024