AccessGUDID - DEVICE: Bisi-Tray (EBIB032501)

GUDID

Device Identifier (DI) Information

Brand Name: Bisi-Tray
Version or Model: 03250
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 03250
Company Name: bisico Bielefelder Dentalsilicone GmbH & Co. KG

Primary DI Number: EBIB032501
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316133664 *Terms of Use

Device Description: A light curing material to be used to create a custom impression tray intended for filling with dental impression materials. 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":	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?
58106	Dental impression tray material	A material intended to be used to create a custom impression tray intended for filling with dental impression materials; it is not intended for the fabrication of a patient-worn dental appliance. The tray is typically made by applying the material to a preliminary plaster or stone model of the patient's teeth and gums. The material is used in cases in which a preformed impression tray is not suitable. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHY	Tray, Impression, Preformed

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
Handling Environment Temperature: between 0 and 27 Degrees Celsius
Storage Environment Temperature: between 0 and 27 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f578ce4f-361f-4210-8575-d9ea5c30edf6
Public Version Date: July 06, 2020
Public Version Number: 1
DI Record Publish Date: June 26, 2020