AccessGUDID - DEVICE: Resin Teeth DCL PE (DIVO5247221)

GUDID

Device Identifier (DI) Information

Brand Name: Resin Teeth DCL PE
Version or Model: 524722
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 524722
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: DIVO5247221
Issuing Agency: HIBCC
Commercial Distribution End Date: May 18, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 448015938 *Terms of Use

Device Description: SR Orthosit PE 8er OT2 4D

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
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: 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: 82b4ee86-be5e-4103-b659-f2afff0b542d
Public Version Date: May 19, 2022
Public Version Number: 2
DI Record Publish Date: January 23, 2019