(110 days)
Addent Inc., Microlux Transilluminator
Not Found
No
The description focuses on a simple fiber optic transilluminator and does not mention any computational analysis, image processing, or AI/ML terms.
No
The device is described as a "diagnostic aid" that helps "locate decay, calculus, fracture lines, endodontic orifices, cracks and fissures." Its function is to visualize existing conditions, not to treat them.
Yes
The "Intended Use / Indications for Use" states that the device is a "diagnostic aid used to locate decay, calculus, fracture lines, endodontic orifices, cracks and fissures underneath the tooth surface". The "Device Description" also explains how it aids in diagnosis by making "dark areas in an otherwise bright structure thus aiding in diagnosis."
No
The device description clearly states it is a "fiber optic transilluminator connected directly to a light source" and describes physical components like a "fiber-optic bundle" and a "stainless steel end-tip," indicating it is a hardware device.
Based on the provided information, the Ti2200 Transillumination Cable is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Ti2200 Transillumination Cable is used to examine the tooth surface directly on the patient.
- The device description clearly states it's used "when placed on the tooth surface". This indicates direct application to the patient, not analysis of a sample.
- The intended use is a "diagnostic aid" for locating issues underneath the tooth surface. While it aids in diagnosis, it does so through direct visualization and light transmission properties of the tooth, not by analyzing biological samples.
Therefore, the Ti2200 Transillumination Cable is a diagnostic device used in vivo (on the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Ti2200 Transillumination Cable is a diagnostic aid used to locate decay, calculus, fracture lines, endodontic orifices, cracks and fissures underneath the tooth surface utilizing a fiber optic cable and handle attached to a light source.
Product codes
NTK
Device Description
The Ti2200 Transillumination Cable is a fiber optic transilluminator connected directly to a light source. The Ti2200 Transillumination Cable uses a 2.1mm fiber-optic bundle with a 45 degree stainless steel end-tip. The end-tip, when placed on the tooth surface (and when other sources of light are minimized), creates an illuminated tooth structure to help locate decay, calculus, fracture lines, endodontic orifices, cracks and fissures. These clinical entities reduce the ability to transmit light and therefore show up as dark areas in an otherwise bright structure thus aiding in diagnosis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth surface
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Addent Inc., Microlux Transilluminator
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image shows the text "K071429" written in a handwritten style at the top. Below this, there is a stylized logo that appears to read "sds" in a bold, sans-serif font, with curved lines accentuating the letters. The logo is positioned above the words "SURGICAL DENTAL SPECIALTIES" written in smaller, uppercase letters.
SYBRON DENTAL SPECIALTIES
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 West Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person
Date Summary Prepared: May 2007
Device Name:
- Trade Name Ti2200 Transillumination Cable .
- Common Name Fiber optic transilluminator ●
- . Classification Name - Laser fluorescence caries detection device, per 21 CFR & 872.1745
Devices for Which Substantial Equivalence is Claimed:
- . Addent Inc., Microlux Transilluminator
Device Description:
The Ti2200 Transillumination Cable is a fiber optic transilluminator connected directly to a light source. The Ti2200 Transillumination Cable uses a 2.1mm fiber-optic bundle with a 45 degree stainless steel end-tip. The end-tip, when placed on the tooth surface (and when other sources of light are minimized), creates an illuminated tooth structure to help locate decay, calculus, fracture lines, endodontic orifices, cracks and fissures. These clinical entities reduce the ability to transmit light and therefore show up as dark areas in an otherwise bright structure thus aiding in diagnosis.
Intended Use of the Device:
The intended use of Ti2200 Transillumination Cable is to locate decay, calculus, fracture lines, endodontic orifices, cracks and fissures underneath the tooth surface.
Substantial Equivalence:
Ti2200 Transillumination Cable is substantially equivalent to other legally marketed devices in the United States. Ti2200 Transillumination Cable functions in a manner similar to and is intended for the same use as the Microlux Transilluminator designed by Addent Inc.
SEP 1 0 2007
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple and recognizable, representing the department's role in providing health and human services to the United States.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 2007
Kerr Corporation C/O Ms. Colleen Boswell Vice President, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
Re: K071429
Trade/Device Name: Ti2200 Transillumination Cable Regulation Number: 21 CFR 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device. Regulatory Class: II Product Code: NTK Dated: August 28, 2007 Received: September 4, 2007
Dear Ms. Boswell:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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.
2
Page 2 - Ms. Boswell
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: Ti2200 Transillumination Cable
Indications for Use:
The Ti2200 Transillumination Cable is a diagnostic aid used to locate decay, calculus, fracture lines, endodontic orifices, cracks and fissures underneath the tooth surface utilizing a fiber optic cable and handle attached to a light source.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
10-1
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
dian Karrar (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K071429 and so on. I am unable to provide any meaningful assistance to you.