AccessGUDID - DEVICE: TRIOS 5 (05902729754149)

GUDID

Device Identifier (DI) Information

Brand Name: TRIOS 5
Version or Model: L1P-1F
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: 3shape Trios A/S

Primary DI Number: 05902729754149
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305225025 *Terms of Use

Device Description: The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries. System includes one TST-11 tip.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63669	Intraoral optical scanning system	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NBL	Laser, Fluorescence Caries Detection

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221249	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Atmospheric Pressure: between 80 and 110 KiloPascal
Storage Environment Humidity: between 10 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between 14 and 122 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: aa720267-0b8b-46c7-a363-ebdc27233abb
Public Version Date: June 24, 2025
Public Version Number: 1
DI Record Publish Date: June 16, 2025