TRANSLEX

GUDID 00810152820742

Orthodontic Ceramic brackets, Roth, slot .022" , Hooks on 3,4,5

Ortho Pro Dent LLC

Orthodontic bracket, ceramic

• Primary Device ID: 00810152820742
• NIH Device Record Key: 2c29e4e2-7bf6-4631-9ab9-b7607ddf1b01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRANSLEX
• Version Model Number: 802R-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	00810152820742 [Primary]

FDA Product Code

• NJM: Bracket, Ceramic, 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 [TRANSLEX]

• 00810152820773: Orthodontic Ceramic brackets, Roth, slot .018" , Hooks on 3,4,5
• 00810152820766: Orthodontic Ceramic brackets, MBT, slot .018" , Hooks on 3,4,5
• 00810152820759: Orthodontic Ceramic brackets, MBT, slot .022" , Hooks on 3,4,5
• 00810152820742: Orthodontic Ceramic brackets, Roth, slot .022" , Hooks on 3,4,5