AccessGUDID - DEVICE: Evanesce™ flow flowable restorative single dose A3E (07540172012263)

GUDID

Device Identifier (DI) Information

Brand Name: Evanesce™ flow flowable restorative single dose A3E
Version or Model: 323533
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 323533
Company Name: CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.

Primary DI Number: 07540172012263
Issuing Agency: GS1
Commercial Distribution End Date: February 14, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 626406016 *Terms of Use

Device Description: Dental Composite Resin

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):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
35870	Dental composite resin	A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. 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 [?]
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: less than 25 Degrees Celsius
Special Storage Condition, Specify: Avoid heat direct sunlight radical starters Avoid contact with alkali metals hydrides strong oxidizing agents and radical initiators

Clinically Relevant Size

[?]

Size Type Text
Weight: 0.25 Gram
Device Size Text, specify: 20x0.25g single dose

Device Record Status

Public Device Record Key: e4f3b230-3fba-4054-9a12-caebcc3ce1b6
Public Version Date: June 24, 2024
Public Version Number: 3
DI Record Publish Date: December 19, 2017