AccessGUDID - DEVICE: Scott's Select ColorFil Flow Single-Shade Prismatic (D77819950611)

GUDID

Device Identifier (DI) Information

Brand Name: Scott's Select ColorFil Flow Single-Shade Prismatic
Version or Model: 199-5061
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 199-5061
Company Name: SCOTT'S DENTAL SUPPLY L.L.C.

Primary DI Number: D77819950611
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 137217043 *Terms of Use

Device Description: ColorFil Flow is a light cure flowable radiopaque composite that color matches to natural tooth shades. This spherical, nano filler composite is ideal for small class I and II restorations, enamel defects and extended fissure sealing. ColorFil Flow features high radiopacity and toothlike opalescence with excellent physical properties and handling. Indicated for: Small class I and II restorations, Small enamel defects, Extended fissure sealings. For more information visit: https://www.scottsdental.com/colorfil-flow-single-shade.html?queryID=44778907d73cbed73829f71103572f05&objectID=49219&indexName=magento2_production_default_products

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?
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
EBC	Sealant, Pit And Fissure, And Conditioner
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
Special Storage Condition, Specify: Keep out of direct sunlight
Storage Environment Temperature: less than 77 Degrees Fahrenheit
Storage Environment Temperature: less than 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 1 Gram

Device Record Status

Public Device Record Key: 4be2a29d-e972-4114-9c2f-67fbfc797c84
Public Version Date: September 04, 2024
Public Version Number: 1
DI Record Publish Date: August 27, 2024