FDA.reportPublic FDA data

TRIOS Dx

Primary DI
05902729754187
Brand
TRIOS Dx
Company
3shape Trios A/S
Model
R1.1
Device description
TRIOS Dx PlusTRIOS Dx is intended as an aid in the diagnosis of oral health conditions and the assessment of changes in teeth and gingiva.
Published
2026-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
SHQDental Image Analyzer, In-Office

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SHQDental Image Analyzer, In-OfficeDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260082000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260082000TRIOS Dx (R1)3Shape TRIOS A/S2026-04-10SHQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05902729754187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05902729754187059027297541875902729754187

GMDN Terms#

Term, Definition table
TermDefinition
Intraoral optical scanning systemAn assembly of electronic devices intended to use optical technology to capture digital topographical 3-D images of teeth, oral cavity structure and geometry, and bite relationship of a patient; it is typically in addition capable of detecting dental caries. It consists of a hand-held intraoral scanner with near infrared (NIR) and laser illumination, and a mobile unit with a user interface with display/controls. The resulting digital dental impressions may be used for CAD/CAM fabrication of dental restorations and orthodontic devices.

Regulatory Flags#

DUNS number
305225025
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05902729754033TRIOS DxR1.y2026-04-23
05902729754040TRIOS DxR1.02026-04-23
05902729754071Trios Move ProC4.22025-10-01
05902729754149TRIOS 5L1P-1F2025-06-16
05902729753722TRIOS 5L1P-1F2022-09-26
05902729753906TRIOS Ready TipTST-152025-05-06
05902729753982TRIOS 6L1P-22025-04-24
05902729754088TRIOS® 3S-tip2025-04-01
05902729750127 TRIOS® 3S-tip2017-10-09
05902729750776 TRIOS®C3B2017-09-06
05902729750059 TRIOS® 3S1-22017-07-26
05902729750066 TRIOS® 3PS1-22017-07-28
05902768365788 TRIOS® 3S1-42017-07-26
05902768365863 TRIOS® 3S1P-22017-07-17
05902768365887 TRIOS® 3S1P-42017-07-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05902729754033TRIOS Dx3shape Trios A/SSHQ2026-04-23
05902729754040TRIOS Dx3shape Trios A/SSHQ2026-04-23