Self-Max

GUDID 00810152820681

Orthodontic Self ligating bracket , Roth ,slot .018" , Hooks on 3,4,5

Ortho Pro Dent LLC

Orthodontic bracket, metal

• Primary Device ID: 00810152820681
• NIH Device Record Key: d2fb9b56-362d-4ac2-b296-44918fabeb86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Self-Max
• Version Model Number: 501R-WH
• Company DUNS: 085719913
• Company Name: Ortho Pro Dent LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 941-402-6504
• Email: edward@orthoprodent.com
• Phone: 941-402-6504
• Email: edward@orthoprodent.com
• Phone: 941-402-6504
• Email: edward@orthoprodent.com
• Phone: 941-402-6504
• Email: edward@orthoprodent.com
• Phone: 941-402-6504
• Email: edward@orthoprodent.com
• Phone: 941-402-6504
• Email: edward@orthoprodent.com
• Phone: 941-402-6504
• Email: edward@orthoprodent.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810152820681 [Primary]

FDA Product Code

• EJF: Bracket, Metal, Orthodontic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-13
• Device Publish Date: 2024-11-05

On-Brand Devices [Self-Max]

• 00810152820698: Orthodontic Self ligating bracket , Roth, slot .022" , Hooks on 3,4,5
• 00810152820681: Orthodontic Self ligating bracket , Roth ,slot .018" , Hooks on 3,4,5
• 00810152820674: Orthodontic Self ligating bracket , MBT ,slot .018" , Hooks on 3,4,5
• 00810152820667: Orthodontic Self ligating bracket , MBT ,slot .022" , Hooks on 3,4,5