AccessGUDID - DEVICE: VarseoSmile Temp (EBGO41024US1)

GUDID

Device Identifier (DI) Information

Brand Name: VarseoSmile Temp
Version or Model: 41024US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 41024US
Company Name: BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG

Primary DI Number: EBGO41024US1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316483072 *Terms of Use

Device Description: No description.

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):	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?
45236	Temporary dental crown/bridge resin	A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBG	Crown And Bridge, Temporary, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K193553	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
Special Storage Condition, Specify: Dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 476a5ccb-4e5b-4dae-92c8-53d521d77d97
Public Version Date: October 29, 2021
Public Version Number: 3
DI Record Publish Date: May 27, 2020