AccessGUDID - DEVICE: BISCO LIGHT PROOF RESINVOIR (D757X80494B1)

GUDID

Device Identifier (DI) Information

Brand Name: BISCO LIGHT PROOF RESINVOIR
Version or Model: X-80494B
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: X-80494B
Company Name: BISCO INC.

Primary DI Number: D757X80494B1
Issuing Agency: HIBCC
Commercial Distribution End Date: February 04, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 053529939 *Terms of Use

Device Description: BISCO LIGHT PROOF RESINVOIR

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?
63877	Dental material mixing surface, chairside, reusable	A slab, tray, or well, or palette with wells intended to be used as a surface for mixing inactive dental component materials chairside to produce a functional dental restorative/impression material that is immediately applied to the oral cavity/teeth of the patient, or extraorally to a dental restoration, during a dental procedure. It is typically made of plastic or glass and the user will ordinarily mix the component materials on or in the device by hand (e.g., with a spatula or brush). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KXR	Applicator, 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: 067bfc5e-23c1-4548-a024-92f9f36c997e
Public Version Date: May 04, 2023
Public Version Number: 3
DI Record Publish Date: October 26, 2018