AccessGUDID - DEVICE: Choice 2 Try-In Paste (00810111540698)

GUDID

Device Identifier (DI) Information

Brand Name: Choice 2 Try-In Paste
Version or Model: C-412B1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C-412B1
Company Name: BISCO INC.

Primary DI Number: 00810111540698
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053529939 *Terms of Use
Previous DI: D757C412B10

Device Description: Choice 2 Try-In Paste B1 2g Syringe

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?
61482	Dental cement trial	A non-sterile substance intended to be used as a guide for selecting a good aesthetic match to the final dental cement to be used in a dental restoration of appliance procedure. It is typically supplied as a water-soluble paste consisting of glycerin, mineral fillers and pigments that does not cure and is intended to be washed off from the restoration and preparation surface prior to final cementation. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBF	MATERIAL, TOOTH SHADE, RESIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K993192	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
Storage Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9f1ec29c-bd78-4c52-b01c-a8bf3d10e8ad
Public Version Date: October 19, 2022
Public Version Number: 1
DI Record Publish Date: October 11, 2022