FDA.reportPublic FDA data

TRIOS 3

Primary DI
05902768365481
Brand
TRIOS 3
Company
3shape Trios A/S
Model
TRIOS 3 Pod for pen grip
Device description
TRIOS 3 Pod for pen grip without scanner
Published
2016-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental RestorationsDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05902768365481PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05902768365481059027683654815902768365481

GMDN Terms#

Term, Definition table
TermDefinition
Dental CAD/CAM system, chairsideAn assembly of software-based devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (specifically prescribed to each patient's needs) dental restorations produced chairside during dental or orthodontic treatment. It typically includes, or is used in conjunction with, three-dimensional (3-D) image acquisition and viewing capabilities that provide values (measurements) for the production phase, software for record collection, treatment planning, simulation and device production, and robotic capabilities for the production of the actual devices to be fitted to the patient.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4570272620support@3shape.com

Regulatory Flags#

DUNS number
305225025
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05902729754149TRIOS 5L1P-1F2025-06-16
05902729753906TRIOS Ready TipTST-152025-05-06
05902729753982TRIOS 6L1P-22025-04-24
05902729754088TRIOS® 3S-tip2025-04-01
05902729754057TRIOS Patient MonitoringR2.32024-10-30
05902729753852TRIOS 3S1P-22024-05-17
05902729753869TRIOS 3S1-22024-05-17
05902729753876TRIOS CoreS1-42024-05-17
05902729753883TRIOS CoreS1P-42024-05-17
05902729753890TRIOS 3PS1-22024-05-17
05902729753838Trios Move+C4.12023-09-06
059027297537913Shape F8P7-41112023-01-18
05902729753272TRIOS Patient Monitoring2.1.42021-05-28
05902729753746TRIOSTB-042022-09-26
05902729753678TRIOSC2BP2022-09-26
05902729753685TRIOSLP1-22022-09-26
05902729753722TRIOS 5L1P-1F2022-09-26
05902729753739TRIOS 5L1-22022-09-26
05902729753760TRIOSTST-112022-09-26
05902729753777TRIOSTSL-012022-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970163089966SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-03-23
06970163089973SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-03-23
06970163089836SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-03-16
D745701181MIL001610150fastdesign.ioPrismatik Dentalcraft, IncNOF2026-03-16
D745701181MIL046710150fastdesign.ioPrismatik Dentalcraft, IncNOF2026-03-16
07540209957482MicronMapperClaronav IncNOF2026-02-10
07540209957499MicronMapperClaronav IncNOF2026-02-10
07540209957505MicronMapperClaronav IncNOF2026-02-10
07540209957512MicronMapperClaronav IncNOF2026-02-10
07540209957529MicronMapperClaronav IncNOF2026-02-10
07540209957536MicronMapperClaronav IncNOF2026-02-10
07540209957543MicronMapperClaronav IncNOF2026-02-10
07540209957550MicronMapperClaronav IncNOF2026-02-10
07540209957567MicronMapperClaronav IncNOF2026-02-10
07540209957574MicronMapperClaronav IncNOF2026-02-10
07540209957581MicronMapperClaronav IncNOF2026-02-10
07540209957604MicronMapperClaronav IncNOF2026-02-10
07540209957611MicronMapperClaronav IncNOF2026-02-10
07540209957628MicronMapperClaronav IncNOF2026-02-10
07540209957635MicronMapperClaronav IncNOF2026-02-10
07540209957642MicronMapperClaronav IncNOF2026-02-10
07540209957659MicronMapperClaronav IncNOF2026-02-10
07540209957666MicronMapper EVOClaronav IncNOF2026-02-10
06970163089812SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-02-06
08800293009894R2 PhotogramMegagen Implant Co. LtdNOF2026-02-06
18800026700873i900 Series Single Use TipMedit Corp.NOF2026-02-03
06970163089546SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-01-31
06970163089553SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-01-31
06970163089560SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-01-31
06970163089577SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-01-31