Bracepaste Band and Build LC

Basic Information

• Brand Name: Bracepaste Band and Build LC
• Primary DI: 00190746059346
• Version / Model: 020-032027
• Catalog Number: 020-032027
• Company Name: AMERICAN ORTHODONTICS CORPORATION
• Labeler DUNS: 044668515
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-05
• Public Version: 1
• Public Version Date: 2022-10-13
• Public Version Status: New
• Public Device Record Key: 2da4eb6e-0806-43d8-bd8b-2ab1c0aaa8a1

Device Description

ADHESIVE BRACEPASTE BAND AND BUILD LC SYRINGE 4/PK

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
EMA	CEMENT, DENTAL	Dental	872.3275	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	00190746059346	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K896249	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 25 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Away from Light