AccessGUDID - DEVICE: BISICO Liquid Hardener A (EBIB008101)

GUDID

Device Identifier (DI) Information

Brand Name: BISICO Liquid Hardener A
Version or Model: 00810
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00810
Company Name: bisico Bielefelder Dentalsilicone GmbH & Co. KG

Primary DI Number: EBIB008101
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316133664 *Terms of Use

Device Description: Liquid hardener (catalyst) for mixing with condensation-curing impression silicones (C-silicones). The product is used in dentistry and in the laboratory.

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":	Yes
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?
35866	Silicone dental impression material	An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBH	Material, Impression Tray, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: e94f5462-e50f-4e24-8a3f-d50103a8e608
Public Version Date: July 06, 2020
Public Version Number: 1
DI Record Publish Date: June 26, 2020