AccessGUDID - DEVICE: SELECT BPA FREE PIT & FISSURE SEALANT KIT OPAQUE (D77819960101)

GUDID

Device Identifier (DI) Information

Brand Name: SELECT BPA FREE PIT & FISSURE SEALANT KIT OPAQUE
Version or Model: 199-6010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 199-6010
Company Name: SCOTT'S DENTAL SUPPLY L.L.C.

Primary DI Number: D77819960101
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 137217043 *Terms of Use

Device Description: Scott's Select BPA-Free Pit & Fissure Sealant kit is indicated for the covering and sealing of pits and fissures in the occlusal surfaces of posterior teeth to aid in the resistance to caries in those surfaces. BPA-Free Pit & Fissure Sealant is a light-cure pit and fissure sealant. It is a very low viscosity resin system with a white opaque color to help identify it's retention at recall appointments. It is contained in a direct delivery syringe system for quick and easy application. It is a diluted HDDMA-UDMA based resin with a white opaquer, a micro-fine silica particle and a photosensitive catalyst system. The Kit contains 4 x 1Gm Syringes of Sealant, 1 3mL bottle of Etchant and 10 applicator tips. Instructions for use and SDS available at https://www.scottsdental.com/pit-fissure-sealant-bpa-free.html

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:	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
KLE	Agent, Tooth Bonding, Resin
EBC	Sealant, Pit And Fissure, And Conditioner

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 2 and 10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 3 Milliliter
Weight: 1 Gram

Device Record Status

Public Device Record Key: 1ebda5ff-1591-454b-bcba-79da9b09ee72
Public Version Date: December 19, 2018
Public Version Number: 3
DI Record Publish Date: May 04, 2017