AccessGUDID - DEVICE: Ti-Core Gray Fast Set (00766054000013)

GUDID

Device Identifier (DI) Information

Brand Name: Ti-Core Gray Fast Set
Version or Model: 805-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 805-00
Company Name: ESSENTIAL DENTAL SYSTEMS, INC.

Primary DI Number: 00766054000013
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 101147171 *Terms of Use

Device Description: Core Material Paste/Paste Chemical Cure Gray Shade Fast Set

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?
47906	Custom-made dental composite resin kit	A collection of customized equipment and supplies intended to be used to apply/polymerize composite resins to fill dental cavities or restore damaged dental tissue. It includes the composite resin, which may be self-, light-, or dual-cured, and additional devices which typically include a dental syringe, a mixing palette, a mixing pad, and brushes; it is customized for a specific patient. This is a single-use device.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K922252	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 60 and 85 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: One 15 gram Jar Base and One 15 gram Jar Catalyst

Device Record Status

Public Device Record Key: f0f1006a-b166-4884-9a86-2dd7192a9097
Public Version Date: November 22, 2023
Public Version Number: 4
DI Record Publish Date: July 01, 2016