discovery®

GUDID J011718742800

Assortment discovery® pearl,McLaugh.18,15-25 / Brackets / For further information please visit our online-shop on our website www.dentaurum.de

DENTAURUM GmbH & Co.KG

Orthodontic bracket, ceramic

• Primary Device ID: J011718742800
• NIH Device Record Key: eb3f3f7b-21d7-4ea6-8a3e-bc2a193274d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: discovery®
• Version Model Number: 718-742-80
• Company DUNS: 315427286
• Company Name: DENTAURUM GmbH & Co.KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J011718742800 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935139

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: 2019-03-29
• Device Publish Date: 2019-03-21

On-Brand Devices [discovery®]

• J011718742850: Assortment discovery® pearl,McLaugh.18,15-45 / Brackets / For further information please visit
• J011718742800: Assortment discovery® pearl,McLaugh.18,15-25 / Brackets / For further information please visit
• J011718741850: Assortment discovery® pearl, Roth 18, 15-45 / Brackets / For further information please visit o
• J011718702830: Assortment discovery® pearl,McLaugh.18,13-43 / Brackets / For further information please visit
• J011718702750: Assortment discovery® pearl,McLaugh.18,15-25 / Brackets / For further information please visit
• J011718702730: Assortment discovery® pearl,McLaugh.18,13-23 / Brackets / For further information please visit
• J011790124000: discovery® Bracket, + 22° Torque, + 5° Angulation for tooth 11
• J011891197000: Bracket assort. discovery® 1 case Roth 22/ For further information please visit our online-sho
• J011891196000: 50 cases discovery® Ricketts Universal 18 Brackets / For further information please visit our
• J011891189000: 10 cases discovery® Ricketts Universal 18 Brackets / For further information please visit our
• J011891188000: 1 case discovery® Ricketts Universal 18 Brackets / For further information please visit our on
• J011891185000: 50 cases discovery® Roth 22 Brackets / For further information please visit our online-shop on
• J011891184000: 10 cases discovery® Roth 22 Brackets / For further information please visit our online-shop on
• J011891183000: 1 case discovery® Roth 22 Brackets / For further information please visit our online-shop on o
• J011891182000: 50 cases discovery® Roth 18 Brackets / For further information please visit our online-shop on
• J011891181000: 10 cases discovery® Roth 18 Brackets / For further information please visit our online-shop on
• J011891180000: 1 case discovery® Roth 18 Brackets / For further information please visit our online-shop on o
• J011790162000: discovery® Bracket, + 14° Torque, + 8° Angulation for tooth 22
• J011790161000: discovery® Bracket, + 14° Torque, + 8° Angulation for tooth 12
• J011790160000: discovery® Bracket with hook, + 7° Torque, + 7° Angulation for tooth 23/43
• J011790159000: discovery® Bracket with hook, + 7° Torque, + 7° Angulation for tooth 13/33
• J011790154000: discovery® Bracket, - 10° Torque, 0° Angulation for tooth 42-41/31-32
• J011790153000: discovery® Bracket, - 10° Torque, 0° Angulation for tooth 42-41/31-32
• J011790125000: discovery® Bracket, + 22° Torque, + 5° Angulation for tooth 21