Ceramco® iC 4850139

GUDID D00148501390

Dentsply International Inc.

Dental appliance fabrication material, ceramic

• Primary Device ID: D00148501390
• NIH Device Record Key: b0b09ef8-5dee-4c01-a3b6-8ee3dc28a8f2
• Commercial Distribution Discontinuation: 2022-05-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Ceramco® iC
• Version Model Number: Dentin Shade Stain SS-419
• Catalog Number: 4850139
• 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: 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

• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D00148501390 [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® iC]

• D00149514290: Contains Ceramco iC Paste Opaques, Paste Opaque Modifiers, Opaque Crystals, Opaceous Dentins, De
• D00149514140: 13 Shades. Contains Ceramco iC Paste Opaques, Paste Opaque Modifiers, Opaque Crystals, Opaceous
• D00149514060: Contains Ceramco iC Paste Opaques, Opaque Crystals, Opaceous Dentin, Dentin, Enamel, High Chroma
• D00149514050: Contains Ceramco iC Dentin/Enamel VS Ingots, Paste Opaques, Stains, and Overglaze
• D00149514040: Contains Ceramco iC Ingots, Enamel, Stains, and Overglaze
• D00149514030: 10 Shades. Contains Ceramco iC Paste Opaques, Paste Opaque Modifiers, Opaque Crystals, Opaceous
• D00148603100: Press-to-Metal Margins SPM Green-Brown
• D00148603090: Press-to-Metal Margins SPM Orange-Brown
• D00148603080: Press-to-Metal Margins PM8
• D00148603070: Press-to-Metal Margins PM7
• D00148603060: Press-to-Metal Margins PM6
• D00148603050: Press-to-Metal Margins PM5
• D00148603040: Press-to-Metal Margins PM4
• D00148603030: Press-to-Metal Margins PM3
• D00148603020: Press-to-Metal Margins PM2
• D00148603010: Press-to-Metal Margins PM1
• D00148506160: Enamel Shade Stain Medium
• D00148506150: Enamel Shade Stain Light
• D00148506140: Enamel Shade Stain Extra Light
• D00148501460: Dentin Shade Stain SS-526
• D00148501450: Dentin Shade Stain SS-525
• D00148501440: Dentin Shade Stain SS-524
• D00148501430: Dentin Shade Stain SS-423
• D00148501420: Dentin Shade Stain SS-422
• D00148501410: Dentin Shade Stain SS-421
• D00148501400: Dentin Shade Stain SS-420
• D00148501390: Dentin Shade Stain SS-419
• D00148501380: Dentin Shade Stain SS-418
• D00148501370: Dentin Shade Stain SS-417
• D00148501360: Dentin Shade Stain SS-316
• D00148501350: Dentin Shade Stain SS-315
• D00148501340: Dentin Shade Stain SS-314
• D00148501330: Dentin Shade Stain SS-313
• D00148501320: Dentin Shade Stain SS-312
• D00148501310: Dentin Shade Stain SS-311
• D00148501300: Dentin Shade Stain SS-310
• D00148501290: Dentin Shade Stain SS-209
• D00148501280: Dentin Shade Stain SS-208
• D00148501270: Dentin Shade Stain SS-207
• D00148501260: Dentin Shade Stain SS-206
• D00148501250: Dentin Shade Stain SS-205
• D00148501240: Dentin Shade Stain SS-204
• D00148501230: Dentin Shade Stain SS-203
• D00148501220: Dentin Shade Stain SS-102
• D00148501210: Dentin Shade Stain SS-101
• D00148501200: Dentin Shade Stain SS-003
• D00148501190: Dentin Shade Stain SS-002
• D00148501180: Dentin Shade Stain SS-001
• D00148501170: Dentin Shade Stain SS-000
• D00148501160: Dentin Shade Stain D4