BRILLIANT Crios 60020022
GUDID J00660020022
BRILLIANT Crios A3 HT 14 Planmill, 5 pcs BRILLIANT Crios is a reinforced composite bloc for the fabrication of permanent, aesthetic single-tooth restorations using a CAD/CAM milling process. BRILLIANT Crios is available in a variety of shades and sizes. Composition: Dental glass, cross-linked methacrylates, amorphous silica.
Coltène/Whaledent AG
Resin dental inlay| Primary Device ID | J00660020022 |
| NIH Device Record Key | 43a28ff4-2931-440c-9022-38ad0d5e52ce |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BRILLIANT Crios |
| Version Model Number | 60020022 |
| Catalog Number | 60020022 |
| Company DUNS | 480017482 |
| Company Name | Coltène/Whaledent AG |
| 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 | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight or other heat sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage: 4-23 °C / 39-73°F |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight or other heat sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage: 4-23 °C / 39-73°F |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight or other heat sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage: 4-23 °C / 39-73°F |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight or other heat sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage: 4-23 °C / 39-73°F |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight or other heat sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage: 4-23 °C / 39-73°F |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight or other heat sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage: 4-23 °C / 39-73°F |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight or other heat sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage: 4-23 °C / 39-73°F |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight or other heat sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage: 4-23 °C / 39-73°F |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight or other heat sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage: 4-23 °C / 39-73°F |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight or other heat sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage: 4-23 °C / 39-73°F |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight or other heat sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage: 4-23 °C / 39-73°F |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight or other heat sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage: 4-23 °C / 39-73°F |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight or other heat sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage: 4-23 °C / 39-73°F |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight or other heat sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage: 4-23 °C / 39-73°F |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight or other heat sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage: 4-23 °C / 39-73°F |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | J00660020022 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K181500
FDA Product Code
| EBF | Material, Tooth Shade, Resin |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-19 |
| Device Publish Date | 2023-06-09 |
On-Brand Devices [BRILLIANT Crios]
| J00660020037 | BRILLIANT Crios Sample Kit Sample kit consisting of BRILLIANT Crios blocks and ONE COAT 7 UNIVER |
| J00660020023 | BRILLIANT Crios B1 HT 14 Planmill, 5 pcs BRILLIANT Crios is a reinforced composite bloc for the |
| J00660020022 | BRILLIANT Crios A3 HT 14 Planmill, 5 pcs BRILLIANT Crios is a reinforced composite bloc for the |
| J00660020021 | BRILLIANT Crios A2 HT 14 Planmill, 5 pcs BRILLIANT Crios is a reinforced composite bloc for the |
| J00660020020 | BRILLIANT Crios A1 HT 14 Planmill, 5 pcs BRILLIANT Crios is a reinforced composite bloc for the |
| J00660020019 | BRILLIANT Crios C2 LT 14 Planmill, 5 pcs BRILLIANT Crios is a reinforced composite bloc for the |
| J00660020018 | BRILLIANT Crios B3 LT 14 Planmill, 5 pcs BRILLIANT Crios is a reinforced composite bloc for the |
| J00660020017 | BRILLIANT Crios B2 LT 14 Planmill, 5 pcs BRILLIANT Crios is a reinforced composite bloc for the |
| J00660020016 | BRILLIANT Crios B1 LT 14 Planmill, 5 pcs BRILLIANT Crios is a reinforced composite bloc for the |
| J00660020015 | BRILLIANT Crios A3.5 LT 14 Planmill, 5 pcs BRILLIANT Crios is a reinforced composite bloc for th |
| J00660020014 | BRILLIANT Crios A3 LT 14 Planmill, 5 pcs BRILLIANT Crios is a reinforced composite bloc for the |
| J00660020013 | BRILLIANT Crios A2 LT 14 Planmill, 5 pcs BRILLIANT Crios is a reinforced composite bloc for the |
| J00660020012 | BRILLIANT Crios A1 LT 14 Planmill, 5 pcs BRILLIANT Crios is a reinforced composite bloc for the |
| J00660020011 | BRILLIANT Crios Bleach LT 14 Planmill, 5 pcs BRILLIANT Crios is a reinforced composite bloc for |
| J00660024179 | BRILLIANT Crios Disc Bleach ST H14 |
| J00660024177 | BRILLIANT Crios Disc Bleach ST H18 |
Trademark Results [BRILLIANT Crios]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BRILLIANT CRIOS 79192476 5225392 Live/Registered |
Coltène/Whaledent AG 2016-03-31 |
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