(78 days)
Not Found
Not Found
No
The summary describes a chemical stain for detecting caries, with no mention of AI, ML, image processing, or data-driven algorithms.
No
The device is a diagnostic tool used for detecting caries by staining, not for treating a condition.
Yes
Explanation: The device is indicated for "detection of caries," which is a diagnostic purpose. It helps identify a disease state.
No
The description indicates a "staining" process for caries detection, which strongly suggests a chemical or physical substance is applied, not a software-only solution.
Based on the provided information, it is highly likely that this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "detection of caries through the staining of the outer layer of carious dentin." This describes a direct application to the patient's tooth structure in vivo (within the living body), not a test performed on a sample taken from the body in vitro (in glass/outside the body).
- Mechanism: The mechanism described is staining, which is a visual aid applied directly to the anatomical site. IVDs typically involve analyzing biological samples like blood, urine, tissue, etc.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples, using reagents to detect specific analytes in a sample, or performing tests in a laboratory setting.
In summary, the description points to a device used directly on the patient's tooth for visual identification, which is characteristic of a diagnostic tool used in vivo, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
CARIES INDICATOR PLUS ( CARIES STAIN ) is indicated for detection of caries through the staining of the outer layer of carious dentin.
Product codes (comma separated list FDA assigned to the subject device)
LFC
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dentin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist professional
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)
"Third party testing shows that the efficacy of our products is comparable or better than other brands which are on the market."
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.
Not Found
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
§ 872.1740 Caries detection device.
(a)
Identification. The caries detection device is a device intended to show the existence of decay in a patient's tooth by use of electrical current.(b)
Classification. Class II.
0
ts Inc.
Image /page/0/Picture/1 description: The image shows the logo for the Dental Manufacturers of America (DMA). The logo features the letters "DMA" in a bold, sans-serif font, stacked above the words "DENTAL MANUFACTURERS OF AMERICA" in a smaller, sans-serif font. The logo is black and white.
603 B Country Club Drive
Bensenville, IL 60106-1329, USA
Phone: 630-238-0275
800-846-7120
Fax: 630-238-0276
Website: www.Amdental.com
E-mail: George@AmDental.com
510(K) SUMMARY: K 994368
an Dental Prod
MAR 1 4 2000
The Safe Medical Devices Act of 1990 requires all persons submitting a premarket notification submission to include either (1) a summary of the safety and effectiveness information in the pre-market notification submission upon which an equivalence determination could be based (510(k) summary), or (2) a statement that safety and effectiveness information will be made available to interested persons upon request (510(k) statement). Safety and effectiveness information, that is relevant to an assessment of substantial equivalence. The information could be descriptive information about the new and predicate device(s), or performance or clinical testing information.
In order to comply with the above requirements, we would like to state that our product's efficacy is comparable with other brands which are on the market.
Third party testing shows that the efficacy of our products is comparable or better than other brands which are on the market.
Regarding the safety of the product, please be advised that the product contains ingredients which have been proven to be safe to be used in the dental industry for many years.If the product accidentally gets into the eye, flush immediately with plenty of water and consult a physician. The product must be handled by a dentist professional according with the instructions and Material Safety Data Sheet, wearing gloves, avoiding contact with skin, and eyes using normal safe practices in a highly professional manner.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a wavy line representing the body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 4 2000
Dr. George Nicolae President and Official Correspondent American Dental Products Inc. 603-B Country Club Drive Bensenville, Illinois 60106-1329
K994368 Re : American Dental Products Caries - Detector Trade Name: Plus Requlatory Class: II Product Code: LFC Dated: December 22, 1999 Received: December 27, 1999
Dear Mr. Nicolae:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
2
Page 2 - Mr. Nicolae
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
603 B C
Bensenville, IL 60106
Phone:
Fax:
Image /page/3/Picture/1 description: The image shows the logo for the Dental Manufacturers of America. The logo is in black and white and features the letters "DMA" in large, bold font. Below the letters, the words "DENTAL MANUFACTURERS OF AMERICA" are written in a smaller font.
603 B Country Club Drive Bensenville, IL 60106-1329, USA
630-238-0275 800-846-7120 Fax: 630-238-0276
Website: www.Amdental.com E-mail: George@AmDental.com
8994368
AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS INDICATIONS FOR USE
CARIES INDICATOR PLUS ( CARIES STAIN ) is indicated for detection of caries through the staining of the outer layer of carious dentin.
ability to replace such qua Warranty: American Dental Products Inc. recognizes its re ty of their products as are proven to be defective. American Dental Products Inc. does not ini action of the use of or the liability to use the products described herein. Before using, the user shall determine the dity for any loss or damage direct or consequen illey of the product for its intended user assumes all risk and liability whatsoever in connection therewith.
ન્નર
Susan Runne
(Division Sign-Off) Division of Dental, Infection Control, and General Hosp 510(k) Number