AccessGUDID - DEVICE: Core-Flo DC Lite (D757AB17410K1)

GUDID

Device Identifier (DI) Information

Brand Name: Core-Flo DC Lite
Version or Model: AB-17410K
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AB-17410K
Company Name: BISCO INC.

Primary DI Number: D757AB17410K1
Issuing Agency: HIBCC
Commercial Distribution End Date: October 10, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 053529939 *Terms of Use

Device Description: Core-Flo DC Lite with Universal Primer Kit

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?
62477	Dental composite resin kit	A collection of non-sterile substances intended for professional use during dental restoration and prosthesis installation/repair which includes composite resin material and additional materials to support restoration (e.g., etching solution, bonding agent, primer, prosthesis bonding agents, unfilled resin sealant/coating agents), and may include dedicated disposable devices associated with application; it does not include non-resin-based cements nor dental prosthesis. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBF	MATERIAL, TOOTH SHADE, RESIN
EID	SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL
KLE	Agent, Tooth Bonding, Resin
KXR	Applicator, Resin

FDA Premarket Submission

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

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: 7a983b72-b86b-4d3e-a90d-6edb7d55c021
Public Version Date: October 11, 2022
Public Version Number: 2
DI Record Publish Date: May 19, 2022