DENTSPLY Sirona® 605501

GUDID D0016055011

Stain Crème

Dentsply International Inc.

Dental appliance fabrication material, ceramic

• Primary Device ID: D0016055011
• NIH Device Record Key: e30e140e-104b-4105-9016-b991178b2dcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DENTSPLY Sirona®
• Version Model Number: Universal
• Catalog Number: 605501
• 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: 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)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
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com

Device Dimensions

• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0016055011 [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: 2025-03-24
• Device Publish Date: 2016-11-04

On-Brand Devices [DENTSPLY Sirona®]

• D0016055401: Overglaze
• D0016055321: Incisal Stain i2
• D0016055311: Incisal Stain i1
• D0016055241: Body Stain S4
• D0016055231: Body Stain S3
• D0016055221: Body Stain S2
• D0016055211: Body Stain S1
• D0016055201: Body Stain S0
• D0016055131: Stain Pink
• D0016055121: Stain Blue
• D0016055111: Stain Chestnut
• D0016055101: Stain Grey
• D0016055091: Stain Purple
• D0016055081: Stain Raspberry
• D0016055071: Stain Violet
• D0016055061: Stain Mahogany
• D0016055051: Stain Olive
• D0016055041: Stain Khaki
• D0016055031: Stain Copper
• D0016055021: Stain Sunset
• D0016055011: Stain Crème
• D0016055001: Stain White
• D0016007001: Universal Stain and Overglaze Kit
• D0016055421: Overglaze High Flu
• D0016055400: Overglaze