(72 days)
Not Found
No
The summary describes a standard digital X-ray sensor and image processing capabilities, but there is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms.
No
The device is used for diagnosis, not for treating or rehabilitating a disease or condition.
Yes
The device is described as collecting dental x-ray photos and converting them into electronic impulses that may be stored and manipulated by dentists for the diagnosis of diseases of the teeth, jaw, and oral structures. This clearly states its use for diagnostic purposes.
No
The device description explicitly states "Digital Dental intraoral Xray Sensor," which is a hardware component. The software mentioned is for processing the data from this sensor.
Based on the provided information, the DentiMax Digital X-ray Imaging System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device function: The DentiMax system is a digital X-ray sensor used to capture images of the teeth, jaw, and oral structures. It converts these images into electronic data for storage and manipulation.
- Intended use: The intended use is for collecting and processing dental X-ray photos for diagnosis of diseases of the teeth, jaw, and oral structures. This is an in vivo diagnostic process (examining the body directly), not an in vitro process (examining samples outside the body).
The device is a medical imaging device used for diagnostic purposes, but it does not involve the analysis of biological samples in a laboratory setting, which is the hallmark of an IVD.
N/A
Intended Use / Indications for Use
DentiMax Digital X-ray Imaging System is intended to be used with standard digital X-ray systems to collect dental x-rays photos and convert them into electronic impulses that may be stored, and manipulated by dentists for the diagnosis of diseases of the teeth, jaw, and oral structures.
Product codes
MUH
Device Description
SENSORH1 Catalog #: SENSORH2 USB Control Boxes: SENSORBOXHI and SENSORBOXH2
This device is intended to be used for dental radiographic examination for the diagnosis of diseases of the teeth, jaw, and oral structures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
teeth, jaw, and oral structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
0
April 25th, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that 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.
Dentimax % Korina Akhondzadeh Consultant KARA & Associates, Inc. 6965 El Camino Real, Suite 105-482 CARLSBAD California 92009
Re: K092547
Trade/Device Name: Dentimax Digital X-Ray Imaging System Sensor Size 1, 2, Dentimax USB Control Box Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source X-ray system Regulatory Class: Class II Product Code: MUH
Dear Korina Akhondzadeh:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 30th, 2009. Specifically, FDA is updating this SE Letter because the Product code was incorrectly identified as MUJ.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Laurel Burk, OHT7: Assistant Director, Office of In Vitro Diagnostics and Radiological Health, +1 (301 796-5933, Laurel.Burk@fda.hhs.gov.
Sincerely,
Digitally signed by
Laurel M. Burk -S
Date: 2022.04.25
09:53:21 -04'00'
Laurel Burk Assistant Director Diagnostic X-ray Systems Team Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
DentiMax % Mr. Korina Akhondzadeh Sr. Regulatory Consultant KARA & Associates, Inc. 6965 El Camino Real, Suite 105-428 CARLSBAD CA 92009
OCT 3 0 2009
Re: K092547
Trade/Device Name: DentiMax Digital X-Ray Imaging System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUJ Dated: August 13, 2009 Received: August 19, 2009
Dear Mr. Akhondzadeh:
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 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janina M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
Page 1 of 1
510(k) Number (if known):
Device Name:
Indications For Use:
DentiMax Digital X-ray Imaging System is intended to be used with standard digital X-ray systems to collect dental x-rays photos and convert them into electronic impulses that may be stored, and manipulated by dentists for the diagnosis of diseases of the teeth, jaw, and oral structures.
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
4
Premarket Notification - DentiMax
Image /page/4/Picture/2 description: The image shows the word "DentiMax" in a bold, sans-serif font. The word is slightly distorted, with a grainy texture. There is a curved line below the word, also with a grainy texture, that appears to be a design element. The overall impression is that the image is a logo or brand name.
510(K) SUMMARY
OCT 30 2009
Submitter's Information:
DentiMax 4115 E. Valley Auto Drive, Suite 101 Mesa, AZ 85206 (480) 396-1798 x 201
Name of contact person:
DentiMax David J. Arnett 4115 E. Valley Auto Drive, Suite 101 Mesa, AZ 85206 (480) 396-1798 x 201
Date the summary was prepared:
August 4, 2009
Name of Device:
Trade/Proprietary Name: DentiMax Digital X-ray Imaging System Common/Usual Name: Intraoral Digital X-ray sensor Extraoral Source Dental X-ray, Digital System Classification Name:
The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:
Description of the device:
SENSORH1 Catalog #: SENSORH2 USB Control Boxes: SENSORBOXHI and SENSORBOXH2
Digital Dental intraoral Xray Sensor
This device is intended to be used for dental radiographic examination for the diagnosis of diseases of the teeth, jaw, and oral structures.
Page 1 of 2
DentiMax, Inc
5
Image /page/5/Picture/1 description: The image shows the word "Dentimax" in a stylized font. The word is in black and is surrounded by a gray, textured shape. The shape appears to be a partial circle or arc that extends from the right side of the word and curves underneath it.
510(K) SUMMARY (continued)
Indications:
Indications for Use (from labeling): DentiMax Digital X-ray Imaging System is intended to be used with standard X-ray systems to collect dental x-rays photos and convert them into electronic data that may be stored, viewed, and manipulated by dentists for the diagnosis of diseases of the teeth, jaw, and oral structures
Summary of the technological characteristics of our device compared to the predicate device:
The predicate Accent™ Sensor Digital X-ray System, manufactured by Air Technique reference number is K050693 and DentiMax Digital X-ray Imaging System were compared and found to have similar technological characteristics and to be equivalent.
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