Right-On Bonding Adhesives

Basic Information

• Brand Name: Right-On Bonding Adhesives
• Primary DI: 00192029000038
• Version / Model: 150-501
• Company Name: TP ORTHODONTICS INC
• Labeler DUNS: 005432299
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-13
• Public Version: 2
• Public Version Date: 2019-12-23
• Public Version Status: Update
• Public Device Record Key: 4c6776b3-a10a-47ac-8db6-7f208ec9c4fa

Device Description

RIGHT-ON SELF CURE BONDING, ONE SYRINGE WITH PASTE 4 g (.141 oz)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DYH	ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN	Dental	872.3750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31750	Orthodontic bracket adhesive	A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192029000038	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 27 Degrees Celsius