equilibrium®

GUDID J011718343500

50 cases equilibrium® 2 Ricketts Univ. 18 Brackets / For further information please visit our online-shop on our website www.dentaurum.de

DENTAURUM GmbH & Co.KG

Orthodontic bracket, metal

• Primary Device ID: J011718343500
• NIH Device Record Key: cbdb7e53-6c84-4881-aa47-40d6dc473d3e
• Commercial Distribution Discontinuation: 2024-06-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: equilibrium®
• Version Model Number: 718-343-50
• 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: false
• 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
• 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
• 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	J011718343500 [Primary]

FDA Product Code

• EJF: BRACKET, METAL, ORTHODONTIC

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-06-19
• Device Publish Date: 2016-09-15

On-Brand Devices [equilibrium®]

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• J011891308010: 10-case-ass. equilibrium® 2 Roth 18 w.h. Brackets / For further information please visit our
• J011790285020: equilibrium® 2 Band bracket with hook, - 7° Torque, 0° Angulation for tooth 25
• J011790284020: equilibrium® 2 Band bracket with hook, - 7° Torque, 0° Angulation for tooth 15
• J011790283020: equilibrium® 2 Band bracket, - 17° Torque, + 2° Angulation for tooth 35
• J011790282020: equilibrium® 2 Band bracket, - 17° Torque, + 2° Angulation for tooth 45
• J011790281020: equilibrium® 2 Band bracket, - 12° Torque, + 2° Angulation for tooth 34
• J011790280020: equilibrium® 2 Band bracket, - 12° Torque, + 2° Angulation for tooth 44
• J011790277020: equilibrium® 2 Band bracket, - 6° Torque, 0° Angulation for tooth 42-41/31-32
• J011790276020: equilibrium® 2 Band bracket, - 7° Torque, 0° Angulation for tooth 15/25
• J011790269020: equilibrium® 2 Band bracket with hook, - 7° Torque, 0° Angulation for tooth 25
• J011790268020: equilibrium® 2 Band bracket with hook, - 7° Torque, 0° Angulation for tooth 15
• J011790267020: equilibrium® 2 Band bracket, - 7° Torque, 0° Angulation for tooth 15/25
• J011790248020: equilibrium® 2 Band bracket with hook, - 17° Torque, + 2° Angulation for tooth 35
• J011790247020: equilibrium® 2 Band bracket with hook, - 17° Torque, + 2° Angulation for tooth 45
• J011790246020: equilibrium® 2 Band bracket with hook, - 12° Torque, + 2° Angulation for tooth 34
• J011790245020: equilibrium® 2 Band bracket with hook, - 12° Torque, + 2° Angulation for tooth 44
• J011790242020: equilibrium® 2 Band bracket, - 17° Torque, + 2° Angulation for tooth 35
• J011790241020: equilibrium® 2 Band bracket, - 17° Torque, + 2° Angulation for tooth 45
• J011790240020: equilibrium® 2 Band bracket, - 12° Torque, + 2° Angulation for tooth 34
• J011790239020: equilibrium® 2 Band bracket, - 12° Torque, + 2° Angulation for tooth 44
• J011790233020: equilibrium® 2 Band bracket, - 6° Torque, 0° Angulation for tooth 42-41/31-32
• J011790219020: equilibrium® 2 Band bracket, - 1° Torque, 0° Angulation for tooth 42-41/31-32
• J011790207020: equilibrium® 2 Band bracket, - 1° Torque, 0° Angulation for tooth 42-41/31-32
• J011790289020: equilibrium® 2 Band bracket with hook, - 17° Torque, + 2° Angulation for tooth 35
• J011790288020: equilibrium® 2 Band bracket with hook, - 17° Torque, + 2° Angulation for tooth 45
• J011790287020: equilibrium® 2 Band bracket with hook, - 12° Torque, + 2° Angulation for tooth 34
• J011790286020: equilibrium® 2 Band bracket with hook, - 12° Torque, + 2° Angulation for tooth 44
• J011790289010: equilibrium® 2 Bracket w.h. -17°Torque,+2°Angulation,18 left
• J011790288010: equilibrium® 2 Bracket w.h. -17°Torque,+2°Angulation,18 right
• J011790287010: equilibrium® 2 Bracket w.h. -12°Torque,+2°Angulation,18 left
• J011790286010: equilibrium® 2 Bracket w.h. -12°Torque,+2°Angulation,18 right
• J011790285010: equilibrium® 2 Bracket w.h. -7°Torque,0°Angulation,18 left
• J011790284010: equilibrium® 2 Bracket w.h. -7°Torque,0°Angulation,18 right
• J011790279010: equilibrium® 2 Bracket w.h. 0°Torque,+3°Angulation,18 left
• J011790275010: equilibrium® 2 Bracket w.h. 0°Torque,+8°Angulation,18 left
• J011790274010: equilibrium® 2 Bracket w.h. 0°Torque,+8°Angulation,18 right
• J011790273010: equilibrium® 2 Bracket +10°Torque,+8°Angulation,18 left
• J011790272010: equilibrium® 2 Bracket +10°Torque,+8°Angulation,18 right
• J011790271010: equilibrium® 2 Bracket +17°Torque,+4°Angulation,18 left
• J011790250010: equilibrium® 2 Bracket w.h. -7°Torque,0°Angulation,18 left
• J011790249010: equilibrium® 2 Bracket w.h. -7°Torque,0°Angulation,18 right
• J011891396010: 1 case equilibrium® 2 Tweed 22 Brackets / For further information please visit our online-sho
• J011891354010: 50-case-ass.equilibrium® 2 McLaugh.18 w.h. Brackets / For further information please visit our
• J011891350010: 10 case-ass.equilibrium® 2 McLaughlin 18 Brackets / For further information please visit our
• J011718343500: 50 cases equilibrium® 2 Ricketts Univ. 18 Brackets / For further information please visit our