AccessGUDID - DEVICE: SCOTT'S SELECT MICROHYBRID COMPULES 15-.3 Gm (B2) (D77819923351)

GUDID

Device Identifier (DI) Information

Brand Name: SCOTT'S SELECT MICROHYBRID COMPULES 15-.3 Gm (B2)
Version or Model: 199-2335
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 199-2335
Company Name: SCOTT'S DENTAL SUPPLY L.L.C.

Primary DI Number: D77819923351
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 15
Labeler D-U-N-S® Number*: 137217043 *Terms of Use

Device Description: Microhybrid composite restorative material. Light-Cure Dental Composite for the aesthetic restoration of anterior and posterior teeth. Radiopaque resin based dental restorative material. Shade/color: B2. SDS and Instructions for use available at: https://www.scottsdental.com/catalog/product/view/id/23294/s/microhybrid-composite-compules-scott-s- select/

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 [?]
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 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: .3 Gram

Device Record Status

Public Device Record Key: 4815d5c2-6996-4dbc-aee6-ee24d4b7fdda
Public Version Date: August 26, 2020
Public Version Number: 5
DI Record Publish Date: May 04, 2017