AccessGUDID - DEVICE: DENTCA Denture Teeth for Carbon Printers (00856551007902)

GUDID

Device Identifier (DI) Information

Brand Name: DENTCA Denture Teeth for Carbon Printers
Version or Model: DENTCA Denture Teeth for Carbon Printers
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DENTCA, INC.

Primary DI Number: 00856551007902
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 022455143 *Terms of Use

Device Description: DENTCA Denture Teeth for Carbon Printers - A1 - 1 kg

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?
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
PZY	Additively Manufactured, Preformed, Resin Denture Tooth

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in a dry place. Do not expose to direct sunlight.
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 1 Kilogram

Device Record Status

Public Device Record Key: 90467140-73c2-4890-8f56-9284e65c64d9
Public Version Date: March 21, 2023
Public Version Number: 2
DI Record Publish Date: October 29, 2021