Celtra® 601600

GUDID D0016016000

Dentsply International Inc.

Dental appliance fabrication material, ceramic

• Primary Device ID: D0016016000
• NIH Device Record Key: c24c498e-0a5b-4fda-849c-ca36e10c6eed
• Commercial Distribution Discontinuation: 2022-05-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Celtra®
• Version Model Number: Duo Starter Kit
• Catalog Number: 601600
• 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: true
• Device Combination Product: false
• Single Use: false
• 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: 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	D0016016000 [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: 2016-11-04

On-Brand Devices [Celtra®]

• D0016015260: Universal Stain Mahogany
• D0016015250: Universal Stain Olive
• D0016015240: Universal Stain Khaki
• D0016015230: Universal Stain Copper
• D0016015220: Universal Stain Sunset
• D0016015210: Universal Stain Crème
• D0016015200: Universal Stain White
• D0016015120: Universal Stain i2
• D0016015110: Universal Stain i1
• D0016015050: Universal Stain Violet
• D0016015040: Universal Stain 4
• D0016015030: Universal Stain 3
• D0016015020: Universal Stain 2
• D0016015010: Universal Stain 1
• D0016015000: Universal Stain 0
• D0016013320: Universal Overglaze
• D0016016010: Duo Stain & Glaze Starter Kit
• D0016016000: Duo Starter Kit
• D0016015900: Starter Kit
• D0016154151: CC Add-On Gingiva G5 - Mahogany
• D0016154141: CC Add-On Gingiva G4 - Dark
• D0016154131: CC Add-On Gingiva G3 - Salmon
• D0016154121: CC Add-On Gingiva G2 - Reddish-Pink
• D0016154111: CC Add-On Gingiva G1 - Pink
• D0016154041: CC Add-On Correction C4 - Transparent
• D0016154031: CC Add-On Correction C3 - Dark
• D0016154021: CC Add-On Correction C2 - Medium
• D0016154011: CC Add-On Correction C1 - Light
• D0016152261: CC Enamel Effect EE6 - Ivory
• D0016152251: CC Enamel Effect EE5 - Sky
• D0016152241: CC Enamel Effect EE4 - Fog
• D0016152231: CC Enamel Effect EE3 - Sunset
• D0016152221: CC Enamel Effect EE2 - Violet
• D0016152211: CC Enamel Effect EE1 - Sunrise
• D0016152161: CC Enamel Opal EO6 LT
• D0016152151: CC Enamel Opal EO5 HT
• D0016152141: CC Enamel Opal EO4 - Transparent
• D0016152131: CC Enamel Opal EO3 - Medium
• D0016152121: CC Enamel Opal EO2 - Light
• D0016152111: CC Enamel Opal EO1 - Extra Light
• D0016152051: CC Enamel E5 - White
• D0016152041: CC Enamel E4 - Transparent
• D0016152031: CC Enamel E3 - Medium
• D0016152021: CC Enamel E2 - Light
• D0016152011: CC Enamel E1 - Extra Light
• D0016151861: Power Dentin PD6
• D0016151851: Power Dentin PD5
• D0016151841: Power Dentin PD4
• D0016151831: Power Dentin PD3
• D0016151821: Power Dentin PD2