Who is the manufacturer of TIA Tip, Cariosity, Transillumination Accessory Tip?

D4D Technologies, LLC filed the 510(k) submission for TIA Tip, Cariosity, Transillumination Accessory Tip (K213482).

What is the FDA product code for TIA Tip, Cariosity, Transillumination Accessory Tip?

NTK. It is classified under 21 CFR 872.1745 as a Class 2 device in the Dental panel.

What is the regulatory pathway for TIA Tip, Cariosity, Transillumination Accessory Tip?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like TIA Tip, Cariosity, Transillumination Accessory Tip?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

TIA Tip, Cariosity, Transillumination Accessory Tip

Q: What are the predicate devices for TIA Tip, Cariosity, Transillumination Accessory Tip?

CamX Triton HD Proxi Head (K172007).

K213482 · D4D Technologies, LLC · NTK · Apr 29, 2022 · Dental

Device Facts

Record ID	K213482
Device Name	TIA Tip, Cariosity, Transillumination Accessory Tip
Applicant	D4D Technologies, LLC
Product Code	NTK · Dental
Decision Date	Apr 29, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.1745
Device Class	Class 2

Intended Use

The TIA Tip is a diagnostic aid for viewing the interproximal areas of dental anatomy to detect and monitor the progression of proximal carious lesions above the gingiva.

Device Story

TIA Tip is an interchangeable accessory for a dental CAD/CAM scanner; used by dentists in clinical settings. Device utilizes 727nm near-infrared (NIR) LEDs to transilluminate dental anatomy; light penetrates enamel/dentin; internal irregularities like caries appear as dark regions. Scanner captures transilluminated images via internal sensor; simultaneously captures full-color images using RGB laser projection. System electronics pulse light sources to interleave frames, enabling side-by-side live visualization of transilluminated and color views on a connected PC. User controls illumination intensity and toggles LED probes (Left/Right/Both) via scanner buttons or software. Static images can be saved for patient documentation and treatment discussion. Device aids in caries detection by revealing proximal cavities not visible via standard color imaging.

Clinical Evidence

No clinical data; bench testing only. Performance evaluated via LED output power measurements, image quality comparisons, and compliance with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 17665-1 (sterilization), and ISO 10993 (biocompatibility: cytotoxicity, irritation, delayed hypersensitivity).

Technological Characteristics

Handheld dental scanner accessory; 727nm NIR LED light source; CMOS imaging sensor. Connectivity via USB 3.0 to PC. Sterilization via autoclave (tip). Biocompatibility per ISO 10993-5/10. Pulsed illumination method. Power source: USB-5V.

Indications for Use

Indicated for dentists to view interproximal dental anatomy to detect and monitor the progression of proximal carious lesions above the gingiva.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

CamX Triton HD Proxi Head (K172007)

Related Devices

K193659 — iTero Element 5D · Align Technology, Inc. · Mar 20, 2020
K240573 — iTero Lumina Pro · Align Technology , Ltd. · Aug 16, 2024
K182712 — DEXIS CariVu 3-in-1 by KaVo · Kaltenbach & Voigt GmbH · Nov 23, 2019
K123402 — DIAGNOCAM · Kaltenbach & Voigt GmbH · Sep 24, 2013
K172007 — CamX Triton HD Proxi Head · Duerr Dental AG · Nov 22, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 29, 2022 D4D Technologies, LLC Eddie Anderson Regulatory Affairs Manager 2920 Telecom Parkway, Suite 100 Richardson, Texas 75082 Re: K213482 Trade/Device Name: TIA Tip, Cariosity, Transillumination Accessory Tip Regulation Number: 21 CFR 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: Class II Product Code: NTK Dated: March 30, 2022 Received: March 31, 2022 Dear Eddie Anderson: 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 (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 located 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. 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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). Sincerely, Michael E. Adjodha, M.ChE. 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213482 Device Name TIA Tip, Cariosity, Transillumination Accessory Tip, P/N 156930xx ### Indications for Use (Describe) The TIA Tip is a diagnostic aid for viewing the interproximal areas of dental anatomy to detect and monitor the progression of proximal carious lesions above the gingiva. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) __ Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image is a logo for E4D Technologies. The logo is a blue circle with a green plus sign in the middle. The circle is broken in four places. The text "E4D TECHNOLOGIES" is below the logo. E4D TECHNOLOGIES ### 510(k) Summary-K213482 #### Sponsor / 510(k) Owner 5.1 D4D Technologies, LLC (dba E4D Technologies) 2920 Telecom Parkway, Suite 100 Richardson, Texas 75082 USA Main: 972-534-3101 ### Contact: Eddie Anderson Regulatory Affairs Manager Direct: 972.534.3101 Email: eanderson@e4d.com #### 5.2 Date Summary Prepared: March 16, 2022 #### 5.3 Device Name | Trade Name(s): | Cariosity; TIA Tip, Transillumination Accessory Tip | |----------------------|-----------------------------------------------------| | Common Name: | Caries Detector, Laser Light, Transmission | | Classification Name: | Laser fluorescence caries detection device | | Regulation Number: | 872.1745 | | Product Code: | NTK | | Device Class: | Class 2 | | Medical Specialty: | Dental | #### Predicate Device(s) 5.4 CamX Triton HD Proxi Head (K172007); Duerr Dental AG #### 5.5 Device Description The TIA Tip is an optional interchangeable component tip assembly that works with the Dental CAD/CAM System Scanner. With the TIA Tip installed the system allows for the simultaneous side by side visualization of live transilluminated and color imaging of the patient's dental anatomy, as well as providing the user with the ability to capture and save transilluminated static images to a patient digital file. The system consists of: - Dental Scanner . - TIA Tip ● - Computer with Software ● With one of the other provided interchangeable scanning tips installed, the system is also used to process dental restorations that are regulated under 21 CFR 872.3661, Optical Impression Systems for CAD/CAM of Dental Restorations. The Scanner is a hand-held electronic device that consists of three parts: the scanner body, the TIA Tip and a custom USB data cable that connects the scanner to the computer. The scanner contains the electrical and opto-mechanical components. The USB cable uses industry standard USB 3.0 type-A and type-C connectors, and the cable assembly is detachable making it easily replaceable. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for E4D Technologies. The logo consists of a stylized letter "E" and "D" formed by a blue circle that is partially broken. Inside the circle, there is a green vertical bar and a horizontal bar that forms the letter "E" and "D". Below the logo, the text "E4D TECHNOLOGIES" is written in bold. 510(k) Summarv The TIA tip must be connected to the scanner to work. It incorporates two "probes" containing Light Emitting Diodes (LEDs) that emit 727nm near infrared light. In operation the probes conform to dental anatomy to direct light into the desired area of inspection. The light penetrates the tooth surface due to the translucent nature of dental anatomy. This allows a user to visualize the inner structure of the tooth and specifically to detect irreqularities like caries that show up as dark areas or spots on the transilluminated image. The scattering light of the illuminated anatomy is reflected by the tip mirror and directed toward the camera in the scanner which allows for a digital image to be captured. The tooth is illuminated with light from both the scanner's laser projection system (RGB) and the TIA Tip LED's. Timing of the light is controlled through the electronics and is divided into separate frames. Collecting and presenting these images at many frames per second allows simultaneous "live" views of transilluminated image and full color view to the system operator. This allows the user to better visualize caries that cannot be detected with standard color imaging. For example, a proximal dental cavity becomes visible as a dark region in the transilluminated image. The software will also allow for the capture of static images throughout the inspection process if the user wishes to document an area of interest and show the patient to discuss treatment options. The software operates on a laptop or desktop pc. A network connection is required for interoperability. When the TIA Tip is installed, it is automatically detected by the scanner and the operator is presented with both a transilluminated view and a live view simultaneously. The operator is provided with controls on the scanner to start/stop and toggle TIA illumination from Both/Right/Left LEDs to enhance TIA viewing. Additionally, on screen controls allow for TIA illumination intensity control for further TIA view optimization. Image capture of simultaneous TIA and live view images is provided which can be used for later reference. No digitization occurs during TIA viewing. ### 5.5.1. Scientific Concept The underlying scientific concept is the use of transillumination, shining light through a body area or organ to check for abnormalities. The 727nm near IR LEDs in the TIA Tip illuminate the internal layers (enamel, dentin, pulp) of a tooth and the imaging sensor in the scanner captures the images in real time. The software displays the black and white 2D transillumination images on a computer screen as a live view and can also store the images for later use. A dentist can then use the images as an aid in the detection and monitoring of caries, or other abnormalities inside the tooth. #### 5.6 Indications for Use The TIA Tip is a diaqnostic aid for viewing the interproximal areas of dental anatomy to detect and monitor the progression of proximal carious lesions above the gingiva. #### 5.7 Summary of technological characteristics / Substantial Equivalence Discussion The following Table compares the Transillumination Accessory (TIA) Tip, P/N 156930xx to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for E4D Technologies. The logo features a stylized design with blue and green elements, resembling a combination of the letters 'E' and 'D'. Below the logo, the text "E4D TECHNOLOGIES" is written in a simple, sans-serif font. Sec510(k) Summary # Table 5A – Comparison of Characteristics | Description | TIA Tip, P/N 156930xx K213482 (Subiect Device) | CamX Triton HD Proxi Head K172007 (Predicate Device) | Device Comparison | |--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | NTK | NTK | Same | | Regulation Number | 872.1745 | 872.1745 | Same | | Indications for Use | The TIA Tip is a diagnostic aid for viewing the interproximal areas of dental anatomy to detect and monitor the progression of proximal carious lesions above the gingiva. | The CamX Triton HD Proxi Head is a diagnostic aid for the detection of interproximal caries lesions above the gingiva and for monitoring the progress of such lesions. | Equivalent – Proximal and Interproximal are used interchangeably. The subject device and the predicate device both use transillumination to view the same area of the dental anatomy and for the same purposes. The difference is that when viewing from the occlusal position, the subject device projects transilluminated light from the buccal/linqual position of the tooth whereas the predicate device projects the transilluminated light from the occlusal position of the teeth. | | Design | Handheld device | Handheld device | Same | | Functional Principle | Transillumination: Based on the principle that tooth enamel is translucent to NIR light. If the light transmission is interrupted due to caries lesions a dark area appears, in normal mode. (Inverse CamX Triton HD Proxi Head) | Transillumination: It makes use of the tooth structure which has the ability of light transmission. If the light transmission is interrupted due to caries lesions a bright area appears. | Equivalent: Both use the principle of transillumination. The difference is that the predicate device indicates the potential carious lesions as bright spots and the TIA Tip provides alternate views in normal, inverted and color. | | Device Components | Handheld device with USB, cable and software installed on a computer. | Handheld device with USB, cable and software installed on a computer. | Same | | Light Source | Two LEDs are used to generate the exact wavelength being detectable by the CMOS sensor. | Two LEDs are used to generate the exact wavelength being detectable by the CMOS sensor. | Same | | Installation | The computer-based installation enables the customer to update the software | The computer-based installation enables the customer to update the software | Same | | Power Source | USB-5V | USB-5V | Same | | Compatibility | USB 3.0 connection | USB connection | Same | | Compliance to Standards | IEC 60601-1 | IEC 60601-1 | Same | | Description | TIA Tip, P/N 156930xx K213482 (Subject Device) | CamX Triton HD Proxi Head K172007 (Predicate Device) | Device Comparison | | Cross Contamination Control | Autoclave (tip of the device) The scanner body (operator contact) is covered with an FDA cleared disposable sheath or barrier material. | Camera cover (single patient disposable sheath, K132953) is placed over the distal end, and an autoclave-able spacer | The entire TIA Tip is autoclavable whereas the predicate device uses a combination of a single patient disposable sheath together with an autoclavable spacer. | | Available Configurations | One Configuration: Handpiece and proprietary software. The handpiece can be connected via USB to a computer. | One Configuration: Handpiece and proprietary software. The handpiece can be connected via USB to a computer (customer provided). | Same | | Software | The software is a computer-based software, which is controlling: - Show / display the pictures - Store / save the pictures - Live Stream (side by side for transilluminated and live color image) – Controlling of camera functions | The software is a computer-based software, which is controlling: - Show / display the pictures - Store / save the pictures - Live Stream – Controlling of camera functions | Equivalent – the TIA Tip has the added feature of being able to show the transilluminated live image and the color live view images side by side, whereas the predicate device only displays the live transilluminated image. | | Intended Users | Dentist | Dentist | Same | | Wavelength | 727 nm | 850 nm | the predicate device uses LEDs with a slightly higher wavelength. The higher wavelength will naturally penetrate better into the tooth. However, this is easily compensated for by adjusting the driving current for LEDs on the subject device to achieve optimal image quality. | | Output Power | 2 LED Sources (transillumination) – Max 3.74mW/cm2 (1.8-1.9 mW/cm² for each LED) measured at the 3.845 mm measuring distance Laser (live color view) - Max 1.12mW/cm² at 100mm measuring distance through a 7mm aperture. | 2 LED sources - Max 2.00 mW/cm² at 7mm measuring distance | Considering the difference in measuring distance of 3.845 vs. 7mm, the LED output power for TIA Tip and CamX Triton are almost the same as measured in side-by-side testing using the same measurement equipment and in the same test environment. The Laser power was measured by TUV in report 7169004049-100. (See page 17-480) | | Description | TIA Tip, P/N 156930xx K213482 (Subject Device) | CamX Triton HD Proxi Head K172007 (Predicate Device) | Device Comparison | | Illumination Type | Pulsed Illumination – method of illumination that consists of periodical light source activation. I.e. alternating ON(pulse)/OFF states. | Continuous Illumination – method of illumination in which the source is activated continuously. | The TIA Tip uses sequential pulses of RBG laser light and NIR LED light to produce side by side transillumination and color live stream images. | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows a circular logo with a combination of blue and green colors. The logo appears to be abstract, with the shapes suggesting a stylized representation of a cross or a plus sign within the circle. The design is modern and clean, with a small swoosh extending from the right side of the circle. # D4D Technologies, LLC 510 Trounnorogios, 220 Transillumination Accessory (TIA) Tip, P/N 156930xx Traditional 510(k) - K213482/Supplement E4D TECHNOLOGIES ### 510(k) Summary {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows a logo for a company called "E4D TECHNOLOGIES". The logo is a stylized circle with a green plus sign in the middle. The circle is blue, and the plus sign is green. The company name is written in black letters below the logo. The logo is simple and modern, and it is likely intended to convey a sense of technology and innovation. E4D TECHNOLOGIES ### 510(k) Summarv #### 5.8 Summary of Nonclinical Performance Testing The TIA Tip was evaluated to demonstrate substantial equivalence based on similar performance to the predicate device, the CamX Triton HD Proxi. Key performance attributes tested and compared include: - a. LED illumination and output power - b. Image Quality Validation and verification test results showed that the subject device and the predicate device are substantially equivalent, and that illumination and image quality of potential caries detection products are similar for both Duerr Dental AG's CamX Triton HD Proxi and E4D's TIA Tip. The TIA Tip complies with the following: - . IEC 60601-1 Edition 3.1 - Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance - . IEC 60601-1-2:2014 – Medical Electrical Equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests - Sterilization validation was conducted in accordance with ISO 17665-1 Sterilization of Health . Care Products – Moist Heat-Part 1 - . Biocompatibility Testing in accordance with the reguired parts of the ISO 10993 series; derived from the ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing There are no known biocompatibility issues associated with any patient contact materials used to manufacture the TIA Tip. The assembled tip was tested and complies with ISO 10993-10 for Irritation and Delayed Hypersensitivity, and ISO 10993-5 for Cytotoxicity. #### 5.9 Summary of Clinical Testing Clinical testing is not required and has not been performed. ### 5.10 Conclusion A comparison of the indications for use, construction materials, and principle of operations, features and technical data show that the TIA Tip is safe and effective for its intended use. Evaluation of the minor technological differences between the subject device and the predicate do not raise any new issues of safety or effectiveness. Based on similarities in indications for use and technological characteristics, together with results of non-clinical performance testing, it is concluded that the TIA Tip is substantially equivalent to the CamX Triton HD Proxi Head system.