AccessGUDID - DEVICE: Visalys Temp (E21713782US1)

GUDID

Device Identifier (DI) Information

Brand Name: Visalys Temp
Version or Model: 13782US
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 13782US
Company Name: Kettenbach GmbH & Co. KG

Primary DI Number: E21713782US1
Issuing Agency: HIBCC
Commercial Distribution End Date: January 11, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 316803246 *Terms of Use

Device Description: Visalys Temp A3 USA Normal pack

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?
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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122039	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: 3ed7fd1c-f20a-443c-b1bd-6b2f207faa33
Public Version Date: October 29, 2021
Public Version Number: 4
DI Record Publish Date: September 15, 2016