ceraMotion®

GUDID J011250438050

ceraMotion® PZr Ingot B3, 5 x 2 g / dental ceramic material

DENTAURUM GmbH & Co.KG

Dental appliance fabrication material, ceramic

• Primary Device ID: J011250438050
• NIH Device Record Key: 277a8d06-ce42-4880-a964-5686cbd39a3e
• Commercial Distribution Discontinuation: 2024-01-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ceraMotion®
• Version Model Number: 250-438-05
• 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	J011250438050 [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

On-Brand Devices [ceraMotion®]

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• J011250318030: ceraMotion® Paste 2D Body L / dental ceramic material
• J011250295030: ceraMotion® Paste 3D Dentin medium / dental ceramic material
• J011250272030: ceraMotion® Paste Glaze bright / dental ceramic material
• J011250336030: ceraMotion® Paste 3D Gingival Modifier / dental ceramic material
• J011250335030: ceraMotion® Paste 3D Gingival transpa / dental ceramic material
• J011250334030: ceraMotion® Paste 3D Gingival white / dental ceramic material
• J011250333030: ceraMotion® Paste 3D Gingival 4 / dental ceramic material
• 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
• J011250319030: ceraMotion® Paste 2D Body R+ / dental ceramic material
• 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
• J011252626200: ceraMotion® Me 3D Dentin CC53, 20 g / dental ceramic material
• J011252625200: ceraMotion® Me 3D Dentin CC52, 20 g / dental ceramic material
• 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
• J011252611200: ceraMotion® Me 3D Dentin CC3-2, 20 g / dental ceramic material
• J011252610200: ceraMotion® Me 3D Dentin CC3-1, 20 g / dental ceramic material
• J011252609200: ceraMotion® Me 3D Dentin CC2+2, 20 g / dental ceramic material
• J011252608200: ceraMotion® Me 3D Dentin CC2+1, 20 g / dental ceramic material
• J011252607200: ceraMotion® Me 3D Dentin CC23, 20 g / dental ceramic material
• J011252606200: ceraMotion® Me 3D Dentin CC22, 20 g / dental ceramic material
• J011252605200: ceraMotion® Me 3D Dentin CC21, 20 g / dental ceramic material
• J011252604200: ceraMotion® Me 3D Dentin CC2-2, 20 g / dental ceramic material
• J011252603200: ceraMotion® Me 3D Dentin CC2-1, 20 g / dental ceramic material
• J011252602200: ceraMotion® Me 3D Dentin CC12, 20 g / dental ceramic material