AccessGUDID - DEVICE: SciPharm NewCore, Core Build-Up Restorative Automix (D801SP57031)

GUDID

Device Identifier (DI) Information

Brand Name: SciPharm NewCore, Core Build-Up Restorative Automix
Version or Model: SP 57-03
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 57-03
Company Name: SCIENTIFIC PHARMACEUTICALS, INC.

Primary DI Number: D801SP57031
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 096010525 *Terms of Use

Device Description: NewCore - Core Build-Up Restorative Material in Automix Cartridges. 50 cc Dual Barrel Cartridge. Blue Shade.

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):	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
EBF	Material, Tooth Shade, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K810479	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: less than 73 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7923b2af-8180-47e3-a0c3-3066738727b9
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 09, 2016