ceraMotion®

GUDID J011252445050

ceraMotion® P+PMe Ingot D3, 5 x 2 g / dental ceramic material

DENTAURUM GmbH & Co.KG

Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic

• Primary Device ID: J011252445050
• NIH Device Record Key: 82c97e71-5e2b-489c-81e3-58c176e4f481
• Commercial Distribution Discontinuation: 2024-01-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ceraMotion®
• Version Model Number: 252-445-05
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J011252445050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011425

FDA Product Code

• EIH: POWDER, PORCELAIN

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: 2024-01-25
• Device Publish Date: 2016-09-15

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• J011250332030: ceraMotion® Paste 3D Gingival 3 / dental ceramic material
• J011250331030: ceraMotion® Paste 3D Gingival 2 / dental ceramic material
• J011250330030: ceraMotion® Paste 3D Gingival 1 / dental ceramic material
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• J011250317030: ceraMotion® Paste 2D Body R / dental ceramic material
• J011250316030: ceraMotion® Paste 2D Incisal I3/ dental ceramic material
• J011250315030: ceraMotion® Paste 2D Incisal I2 / dental ceramic material
• J011250299030: ceraMotion® Paste 3D I3 / dental ceramic material
• J011250298030: ceraMotion® Paste 3D Incisal opal bright / dental ceramic material
• J011250297030: ceraMotion® Paste 3D transpa / dental ceramic material
• J011250296030: ceraMotion® Paste 3D Dentin dark / dental ceramic material
• J011250294030: ceraMotion® Paste 3D Dentin light / dental ceramic material
• J011250293030: ceraMotion® Paste 3D Dentin bleach / dental ceramic material
• J011250432050: ceraMotion® PZr Ingot A2, 5 x 2 g / dental ceramic material
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• J011252624200: ceraMotion® Me 3D Dentin CC51, 20 g / dental ceramic material
• J011252623200: ceraMotion® Me 3D Dentin CC4+2, 20 g / dental ceramic material
• J011252622200: ceraMotion® Me 3D Dentin CC4+1, 20 g / dental ceramic material
• J011252621200: ceraMotion® Me 3D Dentin CC43, 20 g / dental ceramic material
• J011252620200: ceraMotion® Me 3D Dentin CC42, 20 g / dental ceramic material
• J011252619200: ceraMotion® Me 3D Dentin CC41, 20 g / dental ceramic material
• J011252618200: ceraMotion® Me 3D Dentin CC4-2, 20 g / dental ceramic material
• J011252617200: ceraMotion® Me 3D Dentin CC4-1, 20 g / dental ceramic material
• J011252616200: ceraMotion® Me 3D Dentin CC3+2, 20 g / dental ceramic material
• J011252615200: ceraMotion® Me 3D Dentin CC3+1, 20 g / dental ceramic material
• J011252614200: ceraMotion® Me 3D Dentin CC33, 20 g / dental ceramic material
• J011252613200: ceraMotion® Me 3D Dentin CC32, 20 g / dental ceramic material
• J011252612200: ceraMotion® Me 3D Dentin CC31, 20 g / dental ceramic material
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