AccessGUDID - DEVICE: Band-Lok (D798NFBL0)

GUDID

Device Identifier (DI) Information

Brand Name: Band-Lok
Version or Model: NFBL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NFBL
Company Name: RELIANCE ORTHODONTIC PRODUCTS INC

Primary DI Number: D798NFBL0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 113170088 *Terms of Use

Device Description: Band-Lok® is a two paste dual-cure adhesive intended for use as a band cement. Band-Lok Product Features: No messy Powder-Liquid Systems. Consistent mix viscosity every time Unlike Glass Monomer cements, Band-Lok does not have an aftertaste or odor. Better adhesion to enamel and band surfaces is achieved, reducing washout and preventing loose bands Four minute working time at room temperature without a frozen slab. Band-Lok is a Dual Cure cement. It can be used with or without a dental curing light. When band is placed and flash is cleaned a 20 second light activation allows full protection from moisture. Without light activation a complete set is achieved in 10 minutes. Superior Adhesion/Reduced Washout: Band-Lok is a unique combination of Resin and Glass Ionomer technology. This device is NonFluoride Contents of Kit: •(4) 6gm. Syringes of Part A Paste •(4) 6gm. Syringes of Part B Paste •Mixing Pads and Spatulas.

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
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: TEMPERATURE LIMITATION: Store refrigerated (2-8 degrees C.)

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 27c2fd04-2d41-4fed-a6f9-369be5ff8406
Public Version Date: July 24, 2020
Public Version Number: 2
DI Record Publish Date: November 14, 2018