TRIOS®
GUDID 05902768365962
Color calibaration kit
3shape Trios A/S
Dental CAD/CAM system, chairside| Primary Device ID | 05902768365962 |
| NIH Device Record Key | 718e7bb9-e765-4013-9543-6e865c368aef |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRIOS® |
| Version Model Number | P13-Ckit |
| Company DUNS | 305225025 |
| Company Name | 3shape Trios A/S |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Serial Number | true |
| 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 | +4570272620 |
| support@3shape.com | |
| Phone | +4570272620 |
| support@3shape.com | |
| Phone | +4570272620 |
| support@3shape.com | |
| Phone | +4570272620 |
| support@3shape.com | |
| Phone | +4570272620 |
| support@3shape.com | |
| Phone | +4570272620 |
| support@3shape.com | |
| Phone | +4570272620 |
| support@3shape.com | |
| Phone | +4570272620 |
| support@3shape.com | |
| Phone | +4570272620 |
| support@3shape.com | |
| Phone | +4570272620 |
| support@3shape.com | |
| Phone | +4570272620 |
| support@3shape.com | |
| Phone | +4570272620 |
| support@3shape.com | |
| Phone | +4570272620 |
| support@3shape.com | |
| Phone | +4570272620 |
| support@3shape.com | |
| Phone | +4570272620 |
| support@3shape.com | |
| Phone | +4570272620 |
| support@3shape.com | |
| Phone | +4570272620 |
| support@3shape.com | |
| Phone | +4570272620 |
| support@3shape.com | |
| Phone | +4570272620 |
| support@3shape.com | |
| Phone | +4570272620 |
| support@3shape.com | |
| Phone | +4570272620 |
| support@3shape.com | |
| Phone | +4570272620 |
| support@3shape.com | |
| Phone | +4570272620 |
| support@3shape.com | |
| Phone | +4570272620 |
| support@3shape.com | |
| Phone | +4570272620 |
| support@3shape.com | |
| Phone | +4570272620 |
| support@3shape.com | |
| Phone | +4570272620 |
| support@3shape.com | |
| Phone | +4570272620 |
| support@3shape.com | |
| Phone | +4570272620 |
| support@3shape.com | |
| Phone | +4570272620 |
| support@3shape.com |
Operating and Storage Conditions
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 120 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05902768365962 [Primary] |
FDA Product Code
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-02-21 |
| Device Publish Date | 2019-05-14 |
On-Brand Devices [TRIOS®]
| 05902768365740 | Calibration tip |
| 05902768365733 | Scanner tip (autoclavable) |
| 05902729752961 | Cart for Intraoral digital impression system |
| 05902768365962 | Color calibaration kit |
Trademark Results [TRIOS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRIOS 90828507 not registered Live/Pending |
Waters Technologies Corporation 2021-07-14 |
 TRIOS 90687303 not registered Live/Pending |
NORTHERN AGRI BRANDS, LLC 2021-05-03 |
 TRIOS 88484786 not registered Live/Pending |
Patel, Payal P 2019-06-22 |
 TRIOS 87112511 not registered Dead/Abandoned |
Goldstein, Damon T. 2016-07-22 |
 TRIOS 87096130 5425836 Live/Registered |
Vcom International Multimedia Corporation 2016-07-07 |
 TRIOS 86374984 4749718 Live/Registered |
Mizuho Orthopedic Systems, Inc. 2014-08-22 |
 TRIOS 85840035 4530625 Live/Registered |
Gemini, Inc. 2013-02-04 |
 TRIOS 85647089 not registered Dead/Abandoned |
Syracuse University 2012-06-08 |
 TRIOS 79406264 not registered Live/Pending |
Ranir LLC 2024-08-12 |
 TRIOS 79394426 not registered Live/Pending |
Ranir, LLC 2024-04-08 |
 TRIOS 79084414 4010978 Live/Registered |
3Shape A/S 2010-05-19 |
 TRIOS 77915757 not registered Dead/Abandoned |
Noguera, Ishtar 2010-01-20 |
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