Orthocryl®

GUDID J011160501000

Orthocryl® Small pack, transparent pink/ orthodontic acrylics

DENTAURUM GmbH & Co.KG

Orthodontic appliance system, bonded Orthodontic appliance system, bonded Orthodontic appliance system, bonded Orthodontic appliance system, bonded Orthodontic appliance system, bonded Orthodontic appliance system, bonded Orthodontic appliance system, bonded Orthodontic appliance system, bonded Orthodontic appliance system, bonded Orthodontic palate expander/teeth aligner, self-removable Orthodontic palate expander/teeth aligner, self-removable Orthodontic palate expander/teeth aligner, self-removable Orthodontic palate expander/teeth aligner, self-removable Orthodontic palate expander/teeth aligner, self-removable Orthodontic palate expander/teeth aligner, self-removable Orthodontic palate expander/teeth aligner, self-removable Orthodontic palate expander/teeth aligner, self-removable Orthodontic palate expander/teeth aligner, self-removable Orthodontic palate expander/teeth aligner, self-removable Orthodontic palate expander/teeth aligner, self-removable Orthodontic palate expander/teeth aligner, self-removable Orthodontic palate expander/teeth aligner, self-removable Orthodontic palate expander/teeth aligner, self-removable Orthodontic palate expander/teeth aligner, self-removable Orthodontic palate expander/teeth aligner, self-removable

• Primary Device ID: J011160501000
• NIH Device Record Key: f2f7aadb-eac8-401f-b15a-7e4e9dfaa7d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthocryl®
• Version Model Number: 160-501-00
• 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: true
• 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 *Keep in a closed container / Protect from contamination and sunlight as they may cause premature polymerisation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a closed container / Protect from contamination and sunlight as they may cause premature polymerisation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a closed container / Protect from contamination and sunlight as they may cause premature polymerisation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a closed container / Protect from contamination and sunlight as they may cause premature polymerisation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a closed container / Protect from contamination and sunlight as they may cause premature polymerisation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a closed container / Protect from contamination and sunlight as they may cause premature polymerisation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a closed container / Protect from contamination and sunlight as they may cause premature polymerisation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a closed container / Protect from contamination and sunlight as they may cause premature polymerisation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a closed container / Protect from contamination and sunlight as they may cause premature polymerisation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a closed container / Protect from contamination and sunlight as they may cause premature polymerisation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a closed container / Protect from contamination and sunlight as they may cause premature polymerisation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a closed container / Protect from contamination and sunlight as they may cause premature polymerisation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a closed container / Protect from contamination and sunlight as they may cause premature polymerisation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a closed container / Protect from contamination and sunlight as they may cause premature polymerisation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a closed container / Protect from contamination and sunlight as they may cause premature polymerisation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a closed container / Protect from contamination and sunlight as they may cause premature polymerisation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a closed container / Protect from contamination and sunlight as they may cause premature polymerisation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a closed container / Protect from contamination and sunlight as they may cause premature polymerisation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a closed container / Protect from contamination and sunlight as they may cause premature polymerisation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a closed container / Protect from contamination and sunlight as they may cause premature polymerisation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a closed container / Protect from contamination and sunlight as they may cause premature polymerisation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a closed container / Protect from contamination and sunlight as they may cause premature polymerisation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a closed container / Protect from contamination and sunlight as they may cause premature polymerisation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a closed container / Protect from contamination and sunlight as they may cause premature polymerisation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a closed container / Protect from contamination and sunlight as they may cause premature polymerisation.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J011160501000 [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

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