Custom Digital Orthodontics

Basic Information

• Brand Name: Custom Digital Orthodontics
• Primary DI: 00850061082015
• Version / Model: CIBM-100001
• Company Name: Klowen Braces, Inc.
• Labeler DUNS: 119261291
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-21
• Public Version: 4
• Public Version Date: 2025-09-23
• Public Version Status: Update
• Public Device Record Key: cfa2c573-bc97-4ccc-84c5-5a546c85c172

Device Description

Custom brackets and disposable resin applicator tray.

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QJJ	Indirect Bonding Tray	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64010	Orthodontic appliance/positioning tray kit	A collection of dental devices which includes a custom-made positioning tray (indirect bonding tray) intended to position and hold in place a set of included orthodontic appliances (e.g., brackets, buccal tubes, lingual retainers) to bond them to teeth during a single procedure. The components are typically made of synthetic polymer and/or metal materials and include appliances manufactured from an oral cavity impression or oral scan for a specific patient (custom-made). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850061082015	GS1

Customer Contacts

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