AccessGUDID - DEVICE: BISICO Provi Temp K A3 5ml (EBIB735711)

GUDID

Device Identifier (DI) Information

Brand Name: BISICO Provi Temp K A3 5ml
Version or Model: 73571
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 73571
Company Name: bisico Bielefelder Dentalsilicone GmbH & Co. KG

Primary DI Number: EBIB735711
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316133664 *Terms of Use

Device Description: Temporary attachment cement for temporary crowns and bridges.

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?
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 [?]
K010012	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
Handling Environment Temperature: between 8 and 25 Degrees Celsius
Storage Environment Temperature: between 8 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 65dec239-1082-4125-af8e-ce75a14257e0
Public Version Date: October 29, 2021
Public Version Number: 6
DI Record Publish Date: January 18, 2018