Brilliant Crios 60024179
GUDID J00660024179
BRILLIANT Crios Disc Bleach ST H14
Coltène/Whaledent AG
Resin dental inlay Resin dental inlay Resin dental inlay Resin dental inlay Resin dental inlay Resin dental inlay Resin dental inlay Resin dental inlay Resin dental inlay Resin dental inlay Resin dental inlay Resin dental inlay Resin dental inlay Resin dental inlay Resin dental inlay Resin dental inlay Resin dental inlay| Primary Device ID | J00660024179 |
| NIH Device Record Key | 7400b983-9c7d-49b4-b093-a31e9342b199 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Brilliant Crios |
| Version Model Number | 60024179 |
| Catalog Number | 60024179 |
| 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 | |
| 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 |
| 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 | J00660024179 [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 | 2023-08-11 |
| Device Publish Date | 2023-08-03 |
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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