Ceramco® 3 301807

GUDID D0013018070

Dentsply International Inc.

Dental appliance fabrication material, ceramic

• Primary Device ID: D0013018070
• NIH Device Record Key: aee18d75-af69-4d4c-b9d6-5af43bdcc37b
• Commercial Distribution Discontinuation: 2022-04-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Ceramco® 3
• Version Model Number: SoftWear Enamels Orange
• Catalog Number: 301807
• Company DUNS: 606173334
• Company Name: Dentsply International Inc.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com

Device Dimensions

• Weight: 28.4 Gram
• Weight: 28.4 Gram
• Weight: 28.4 Gram
• Weight: 28.4 Gram
• Weight: 28.4 Gram
• Weight: 28.4 Gram
• Weight: 28.4 Gram
• Weight: 28.4 Gram
• Weight: 28.4 Gram
• Weight: 28.4 Gram
• Weight: 28.4 Gram
• Weight: 28.4 Gram
• Weight: 28.4 Gram

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0013018070 [Primary]

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: 4
• Public Version Date: 2022-05-06
• Device Publish Date: 2016-09-21

On-Brand Devices [Ceramco® 3]

• D0013030040: 26 Shade Powder Opaque
• D0013030030: 26 Shade Paste Opaque
• D0013030020: Shade Series Trial Kit C3-312
• D0013030010: Powder Opaque Kit
• D0013030000: Paste Opaque Kit
• D0013018080: SoftWear Enamels Super Clear
• D0013018070: SoftWear Enamels Orange
• D0013018060: SoftWear Enamels Violet
• D0013018050: SoftWear Enamels Ivory
• D0013018040: SoftWear Enamels Dark
• D0013018030: SoftWear Enamels Medium
• D0013018020: SoftWear Enamels Light
• D0013018010: SoftWear Enamels Extra Light
• D0013018000: SoftWear Enamels White
• D0013016100: System Evaluation Kit
• D0013016060: Illumine Paste Opaque Kit
• D0013016050: With Powder Opaque Kit
• D0013016040: With Paste Opaque Kit
• D0013016030: With Powder Opaque Kit
• D0013016020: With Paste Opaque Kit
• D0013016010: Shade i4 Trial Kit
• D0013015110: Stain Amber
• D0013015170: Stain Orange Tint
• D0013015160: Stain Yellow Tint
• D0013015150: Stain Brown Tint
• D0013015140: Stain Orange
• D0013015130: Stain Yellow
• D0013015120: Stain Brown
• D0013015100: Stain Peach
• D0013015090: Stain Ochre
• D0013015080: Stain Banana
• D0013015070: Stain Green
• D0013015060: Stain Blue
• D0013015050: Stain Violet
• D0013015040: Stain Rose
• D0013015030: Stain Black
• D0013015020: Stain Shale
• D0013015010: Stain Gray
• D0013015000: Stain White
• D0013042071: Natural Enamel Orange
• D0013042061: Natural Enamel Violet
• D0013041301: Dentin i1
• D0013041171: Opaceous Dentin C1
• D0013041131: Opaceous Dentin B1
• D0013041091: Opaceous Dentin A2
• D0013041061: Opaceous Dentin i7
• D0013041031: Opaceous Dentin i4
• D0013041021: Opaceous Dentin i3
• D0013041001: Opaceous Dentin i1
• D0013040221: Powder Opaque D3