Orthocryl®

GUDID J011161607000

Orthocryl® Disco glitter, blue

DENTAURUM GmbH & Co.KG

Orthodontic appliance system, bonded

• Primary Device ID: J011161607000
• NIH Device Record Key: 74b0b7ab-e62a-49f4-a14b-82ca24908a0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthocryl®
• Version Model Number: 161-607-00
• 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
• 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
• 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
• 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	J011161607000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942667

FDA Product Code

• KMY: POSITIONER, TOOTH, PREFORMED

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-02-05
• Device Publish Date: 2016-09-15

On-Brand Devices [Orthocryl®]

• J011161139000: Orthocryl® liquid, neon blue
• J011161912000: Orthocryl® assortment, clear / orthodontic acrylics / For further information please visit our
• J011161622000: Orthocryl® Color concentrate, blue/ orthodontic acrylics
• J011161620000: Orthocryl® Color concentrate, red/ orthodontic acrylics
• J011161611000: Orthocryl® Disco glitter, mother of pearl
• J011161609000: Orthocryl® Disco glitter, gold
• J011161608000: Orthocryl® Disco glitter, silver
• J011161607000: Orthocryl® Disco glitter, blue
• J011161606000: Orthocryl® Disco glitter, red
• J011161605000: Orthocryl® Disco glitter, iris
• J011161350000: Orthocryl® liquid, transparent pink/ orthodontic acrylics
• J011161300000: Orthocryl® liquid, transparent pink/ orthodontic acrylics
• J011161229000: Orthocryl® liquid "Somno blue"
• J011161227000: Orthocryl® liquid "Somno pink"
• J011161150000: Orthocryl® liquid, clear/ orthodontic acrylics
• J011161138000: Orthocryl® liquid, neon green / orthodontic acrylics
• J011161137000: Orthocryl® liquid, neon pink / orthodontic acrylics
• J011161136000: Orthocryl® liquid, neon orange / orthodontic acrylics
• J011161135000: Orthocryl® liquid, neon yellow / orthodontic acrylics
• J011161134000: Orthocryl® liquid, violet / orthodontic acrylics
• J011161133000: Orthocryl® liquid, emerald green / orthodontic acrylics
• J011161132000: Orthocryl® liquid, hot pink / orthodontic acrylics
• J011161131000: Orthocryl® liquid, turquois/ orthodontic acrylics
• J011161130000: Orthocryl® liquid, yellow/ orthodontic acrylics
• J011161129000: Orthocryl® liquid, blue/ orthodontic acrylics
• J011161128000: Orthocryl® liquid, green/ orthodontic acrylics
• J011161127000: Orthocryl® liquid, red/ orthodontic acrylics
• J011161100000: Orthocryl® liquid, clear/ orthodontic acrylics
• J011160700000: Orthocryl® assortment, neon colors / orthodontic acrylics / For further information please visi
• J011160600000: Orthocryl®assortm."Multicolored palette" / orthodontic acrylics / For further information pleas
• J011160502000: Orthocryl® Small pack, clear/ orthodontic acrylics
• J011160501000: Orthocryl® Small pack, transparent pink/ orthodontic acrylics
• J011160410000: Bite paste for Orthocryl® LC, transparent
• J011160406000: Orthocryl® LC, green/ orthodontic acrylics
• J011160405000: Orthocryl® LC, yellow/ orthodontic acrylics
• J011160404000: Orthocryl® LC, blue/ orthodontic acrylics
• J011160403000: Orthocryl® LC, red/ orthodontic acrylics
• J011160402000: Orthocryl® LC, transparent pink/ orthodontic acrylics
• J011160401000: Orthocryl® LC, clear/ orthodontic acrylics
• J011160400200: Orthocryl® LC Start-Set, clear / orthodontic acrylics / For further information please visit ou
• J011160400000: Orthocryl® LC Start-Set german / orthodontic acrylics / For further information please visit ou
• J011160301000: Orthocryl® EQ powder, clear/ orthodontic acrylics
• J011160300000: Orthocryl® EQ powder, clear/ orthodontic acrylics
• J011160212000: Orthocryl® powder, clear/ orthodontic acrylics
• J011160112000: Orthocryl® powder, clear/ orthodontic acrylics
• J011160014000: Orthocryl® white powder/ orthodontic acrylics
• J011160013000: Orthocryl® black powder/ orthodontic acrylics
• J011160012000: Orthocryl® white powder/ orthodontic acrylics
• J011160011000: Orthocryl® black powder/ orthodontic acrylics