FDA.reportPublic FDA data

TRIOS 5

Primary DI
05902729754149
Brand
TRIOS 5
Company
3shape Trios A/S
Model
L1P-1F
Device description
The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries. System includes one TST-11 tip.
Published
2025-06-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NBLLaser, Fluorescence Caries Detection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBLLaser, Fluorescence Caries DetectionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221249000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221249000L1P-1F (TRIOS 5)3Shape TRIOS A/S2022-09-16NBL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05902729754149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05902729754149059027297541495902729754149

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure80 KiloPascal110 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature14 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
305225025
Device count
1
Serial number
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
05902729754187TRIOS DxR1.12026-04-23
05902729754071Trios Move ProC4.22025-10-01
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
E27668082030Primescan 2SIRONA Dental Systems GmbHNBL2025-11-21
E27668082450Primescan 2SIRONA Dental Systems GmbHNBL2025-10-23
E27668053651Primescan 2 Multiuse SleeveSIRONA Dental Systems GmbHNBL2025-09-16
E27668558402Primescan 2SIRONA Dental Systems GmbHNBL2025-08-20
E27668020400Primescan 2SIRONA Dental Systems GmbHNBL2025-05-16
05902729753906TRIOS Ready Tip3shape Trios A/SNBL2025-05-06
06977585090143Fluorescence ModeCarl Zeiss Meditec (Suzhou) Co., Ltd.NBL2025-03-26
04262352350035DI ScanZetta25 AGNBL2025-02-21
EKAV101537000DIAGNOcam Vision Full HDKaVo Dental GmbHNBL2024-12-03
08800043200090AIOBIOAIOBIO CO.,LTDNBL2024-12-02
08809941490008SmartoothSmartooth Co., Ltd.NBL2024-07-22
08809941490121SmartoothSmartooth Co., Ltd.NBL2024-07-22
08809941490084SmartoothSmartooth Co., Ltd.NBL2024-07-22
03760278267587ACTEONSOPRONBL2024-05-02
EKAV101112130DIAGNOcam Vision Full HDKaVo Dental GmbHNBL2024-02-01
EKAV101315000DIAGNOcam Vision Full HDKaVo Dental GmbHNBL2024-02-01
00858197004062Ortek Therapeutics, Inc. ORTEK THERAPEUTICS, INCNBL2022-12-21
05902729753661TRIOS3shape Trios A/SNBL2022-09-26
05902729753753TRIOS3shape Trios A/SNBL2022-09-26
05902729753746TRIOS3shape Trios A/SNBL2022-09-26
05902729753678TRIOS3shape Trios A/SNBL2022-09-26
05902729753685TRIOS3shape Trios A/SNBL2022-09-26
05902729753722TRIOS 53shape Trios A/SNBL2022-09-26
05902729753739TRIOS 53shape Trios A/SNBL2022-09-26
05902729753760TRIOS3shape Trios A/SNBL2022-09-26
05902729753777TRIOS3shape Trios A/SNBL2022-09-26
05902729753784TRIOS3shape Trios A/SNBL2022-09-26
E247J27121CamX Spectra Interchangeable HeadDÜRR DENTAL SENBL2022-03-04
08800025400135InspireGOOD DOCTORS CO., LTD.NBL2020-11-13
03760278260304ACTEONSOPRONBL2019-03-13