prime4me®

GUDID J011430120300

prime4me® RETAIN3R maxilla

DENTAURUM GmbH & Co.KG

Orthodontic retainer

• Primary Device ID: J011430120300
• NIH Device Record Key: 3392a353-0403-492b-a68a-01fcde879770
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: prime4me®
• Version Model Number: 430-120-30
• Company DUNS: 315427286
• Company Name: DENTAURUM GmbH & Co.KG
• 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J011430120300 [Primary]

FDA Product Code

• DYJ: RETAINER, SCREW EXPANSION, 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: 2025-07-18
• Device Publish Date: 2025-07-10

Devices Manufactured by DENTAURUM GmbH & Co.KG

• J011430120300 - prime4me®: 2025-07-18prime4me® RETAIN3R maxilla
• J011430120300 - prime4me®: 2025-07-18 prime4me® RETAIN3R maxilla
• J011790204020 - equilibrium®: 2025-06-25 equilibrium® 2 Band bracket with hook, - 2° Torque, + 13° Angulation for tooth 13
• J011790205020 - equilibrium®: 2025-06-25 equilibrium® 2 Band bracket with hook, - 2° Torque, + 13° Angulation for tooth 23
• J011790208020 - equilibrium®: 2025-06-25 equilibrium® 2 Band bracket with hook, - 11° Torque, + 7° Angulation for tooth 43
• J011790209020 - equilibrium®: 2025-06-25 equilibrium® 2 Band bracket with hook, - 11° Torque, + 7° Angulation for tooth 33
• J011790216020 - equilibrium®: 2025-06-25 equilibrium® 2 Band bracket with hook, - 2° Torque, + 13° Angulation for tooth 13
• J011790217020 - equilibrium®: 2025-06-25 equilibrium® 2 Band bracket with hook, - 2° Torque, + 13° Angulation for tooth 23
• J011790220020 - equilibrium®: 2025-06-25 equilibrium® 2 Band bracket with hook, - 11° Torque, + 7° Angulation for tooth 43