(260 days)
Not Found
No.
The document explicitly states "Not Found" for the section "Mentions AI, DNN, or ML", and the description of the device's functional principle does not include any mention of AI models for image processing or diagnosis. The "TRIOS Patient Monitoring software which aids in diagnosis" does not inherently mean it uses an AI model, and the performance studies listed are primarily risk analyses and non-clinical tests without mentioning AI model performance metrics.
No.
The device is intended for aid in diagnosis of caries, not for treating any condition.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that "The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries." This directly indicates its diagnostic purpose.
No
The device is not a software-only medical device. The description clearly states it consists of a "scanner and a detachable scanner tip," uses "Light Emitting Diodes (LEDs)," collects "images of the object scanned," and has modifications for a "single-use tip." These are all hardware components involved in the primary function of the medical device, even though there is also software involved in data processing.
No.
The device directly interacts with the human body (intraoral scanner) to collect images, and while it aids in diagnosis, it does not perform in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries.
Product codes (comma separated list FDA assigned to the subject device)
NBL
Device Description
The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries.
The L1P-1F system consists of a scanner and a detachable scanner tip which enables scanning using white and blue (fluorescence) Light Emitting Diodes (LEDs). A single-use scanner body sleeve is mounted on the scanner before being introduced into the mouth of a patient for scanning of the teeth.
The interface to the computer is handled by ScanSuite TRIOS which functions as a Hardware Abstraction Layer (HAL). The scan control of, and data transmission from the scanner is handled by the TRIOS module software, which holds the interface to the user.
The L1P-1F system also consists of the TRIOS Patient Monitoring software which aids in diagnosis of occlusal and surface caries.
The functional principle of L1P-1F (TRIOS 5) is to collect images of the object scanned by means of focus scanning, where light from the LEDs travels through the optical system to the object being scanned and back to an image sensor. 3D data collected by combining blue and white light in turn.
3Shape TRIOS A/S modifies L1P-1F (TRIOS 5) to include a single-use tip, TRIOS Ready Tip (TST-15), as an alternative to the already cleared reusable tip (TST-11).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were performed to verify and/or validate the identified adequate risk control measures following FDA-recognized standards:
- ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- ISO 14644-1: Cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness by particle concentration
- ISO 14698-1: Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 1: General Principles and Methods
- ISO 14698-2: Cleanrooms and associated controlled environments – Biocontamination control – Part 2: Evaluation and interpretation of biocontamination data
- ASTM D3078: Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
- ASTM F1671/F1671M: Standard Practice for Leaks Using Bubble Emission Techniques
- IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- IEC 62366-1: Medical devices. Application of usability engineering to medical devices
- IEC 62471: Photobiological safety of lamps and lamp systems
It was concluded that, in terms of safety and effectiveness, the subject device is substantial equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.1745 Laser fluorescence caries detection device.
(a)
Identification. A laser fluorescence caries detection device is a laser, a fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as well as variable tone emitting and fluorescence measurement functions. The intended use of the device is to aid in the detection of tooth decay by measuring increased laser induced fluorescence.(b)
Classification. Class II, subject to the following special controls:(1) Sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;
(2) Premarket notifications must include clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and
(3) The labeling must include detailed use instructions with precautions that urge users to:
(i) Read and understand all directions before using the device,
(ii) Store probe tips under proper conditions,
(iii) Properly sterilize the emitter-detector handpick before each use, and
(iv) Properly maintain and handle the instrument in the specified manner and condition.
FDA 510(k) Clearance Letter - TRIOS 5 (L1P-1F)
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.07.05
Silver Spring, MD 20993
www.fda.gov
April 4, 2025
3Shape TRIOS A/S
Klaus Hoj
Senior Regulatory Affairs Specialist
Holmens Kanal 7
Copenhagen, Dk-1060
Denmark
Re: K242103
Trade/Device Name: TRIOS 5 (L1P-1F)
Regulation Number: 21 CFR 872.1745
Regulation Name: Laser Fluorescence Caries Detection Device
Regulatory Class: Class II
Product Code: NBL
Dated: March 6, 2025
Received: March 7, 2025
Dear Klaus Hoj:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
Page 2
K242103 - Klaus Hoj Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Page 3
K242103 - Klaus Hoj Page 3
Sincerely,
Bobak Shirmohammadi -S
For Michael E. Adjodha, M.ChE., RAC, CQIA
Assistant Director
DHT1B: Division of Dental and ENT Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
Indications for Use
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.
Please provide the device trade name(s).
TRIOS 5 (L1P-1F)
Please provide your Indications for Use below.
The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries.
Please select the types of uses (select one or both, as applicable).
- ☑ Prescription Use (Part 21 CFR 801 Subpart D)
- ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
TRIOS 5 Page 12 of 46
Page 5
510(k) Summary
510(k)#: K242103
Prepared on: 2025-04-03
Contact Details
21 CFR 807.92(a)(1)
| Field | Value |
|---|---|
| Applicant Name | 3Shape TRIOS A/S |
| Applicant Address | Holmens Kanal 7 Copenhagen 1060 Denmark |
| Applicant Contact Telephone | +4531488032 |
| Applicant Contact | Mr. Klaus Høj |
| Applicant Contact Email | Klaus_r@3shape.com |
Device Name
21 CFR 807.92(a)(2)
| Field | Value |
|---|---|
| Device Trade Name | TRIOS 5 (L1P-1F) |
| Common Name | Laser fluorescence caries detection device |
| Classification Name | Laser, Fluorescence Caries Detection |
| Regulation Number | 872.1745 |
| Product Code(s) | NBL |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K221249 | TRIOS 5 (L1P-1F) | NBL |
Device Description Summary
21 CFR 807.92(a)(4)
The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries.
The L1P-1F system consists of a scanner and a detachable scanner tip which enables scanning using white and blue (fluorescence) Light Emitting Diodes (LEDs). A single-use scanner body sleeve is mounted on the scanner before being introduced into the mouth of a patient for scanning of the teeth.
The interface to the computer is handled by ScanSuite TRIOS which functions as a Hardware Abstraction Layer (HAL). The scan control of, and data transmission from the scanner is handled by the TRIOS module software, which holds the interface to the user.
The L1P-1F system also consists of the TRIOS Patient Monitoring software which aids in diagnosis of occlusal and surface caries.
The functional principle of L1P-1F (TRIOS 5) is to collect images of the object scanned by means of focus scanning, where light from the LEDs travels through the optical system to the object being scanned and back to an image sensor. 3D data collected by combining blue and white light in turn.
3Shape TRIOS A/S modifies L1P-1F (TRIOS 5) to include a single-use tip, TRIOS Ready Tip (TST-15), as an alternative to the already cleared reusable tip (TST-11).
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries.
Page 6
Indications for Use Comparison
21 CFR 807.92(a)(5)
The indications for use for the subject device is the same as the predicate device:
The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries.
Technological Comparison
21 CFR 807.92(a)(6)
The only difference between the subject and predicate device is the introduction of the TRIOS Ready Tip (TST-15) which is a single use tip that can be used as an alternative to the existing reusable tip (TST-11).
The TRIOS Ready Tip (TST-15) has the same function as the reusable tip (TST-11) included in 510(k) premarket notification K221249 in, together with a scanner body sleeve (Body Sleeve), constituting an adequate barrier to reduce the risk of microbial contamination and thereby ease cleaning and disinfection procedures between patients.
A risk analysis was conducted to assess the impact of modifying L1P-1F (TRIOS 5) to include TRIOS Ready Tip (TST-15) as an alternative to the existing reusable tip (TST-11) and adequate risk control measures to mitigate identified risks have been implemented.
Therefore, any differences in technological characteristics between the subject and the predicate device caused by the introduction of the TRIOS Ready Tip (TST-15), does not raise different questions of safety and effectiveness.
Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
3Shape TRIOS A/S modifies L1P-1F (TRIOS 5) to include a single-use tip, TRIOS Ready Tip (TST-15), as an alternative to the already cleared reusable tip (TST-11).
A risk analysis according to ISO 14971 was conducted to assess the impact of the modification thereby identifying adequate risk control measures to mitigate the identified risks.
Non-clinical tests were performed to verify and/or validate the identified adequate risk control measures following FDA-recognized standards:
- ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- ISO 14644-1: Cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness by particle concentration
- ISO 14698-1: Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 1: General Principles and Methods
- ISO 14698-2: Cleanrooms and associated controlled environments – Biocontamination control – Part 2: Evaluation and interpretation of biocontamination data
- ASTM D3078: Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
- ASTM F1671/F1671M: Standard Practice for Leaks Using Bubble Emission Techniques
- IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- IEC 62366-1: Medical devices. Application of usability engineering to medical devices
- IEC 62471: Photobiological safety of lamps and lamp systems
It was concluded that, in terms of safety and effectiveness, the subject device is substantial equivalent to the predicate device.