(81 days)
Not Found
Not Found
No
The summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The device appears to be a desensitizer with fluoride.
Yes
The device is used to desensitize teeth with fluoride, which is a treatment for sensitivity, indicating a therapeutic purpose.
No
The device, a "DESENSITIZER USE WITH FLUORIDE FOR SENSITIVE [teeth]," is intended for treatment (desensitization) rather than diagnosis. Its function is to alleviate sensitivity, not to identify or characterize a condition.
No
The provided text describes a product intended for use with fluoride for sensitive teeth, handled by a dental professional. It mentions efficacy testing compared to other brands on the market. There is no mention of software, algorithms, data processing, or any other characteristics typically associated with a software-only medical device. The description points towards a physical product (likely a dental material or treatment).
Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic). Here's why:
- Intended Use: The intended use is "DESENSITIZER USE WITH FLUORIDE FOR SENSITIVE". This describes a product applied to a patient to treat sensitivity, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: While "Not Found" for the description, the intended use strongly suggests a topical application.
- No mention of biological samples: There is no indication that this device interacts with or analyzes biological samples (like blood, urine, tissue, etc.), which is a core characteristic of IVDs.
- Intended User: The intended user is a "dentist professional," which aligns with a treatment applied in a clinical setting, not a diagnostic test.
- Performance Studies: The description of performance studies mentions "efficacy" and comparison to other brands on the market, which is typical for therapeutic or treatment devices, not diagnostic devices.
In summary, the information points towards a product used for treating tooth sensitivity, which falls outside the scope of In Vitro Diagnostics. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
HB-35 DESENSITIZER USE WITH FLUORIDE FOR SENSITIVE TEETH
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
"The product must be handled by a 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
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
0
K973185
Dental Products Inc.
22 w
Medinah,
Image /page/0/Picture/4 description: The image shows the logo for the Digital Manufacturers of Nevada (DMN). The logo is in black and white and features the letters "DMN" in a bold, stylized font. Above the logo is the date "1 4 1997".
22 W 246 Sunnyside Rd. Medinah Minois 60157-9705, USA phone / fax: (630) 351-6284
510 ( K ) SUMMARY OF THE SAFETY AND EFFECTIVENESS . K 973185
The Safe Medical Devices Act of 1990 requires all persons submitting a premarket notification submission to include cither (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 offectiveness 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 Fluoride, Quals and other ingredients which have been proven to be safe to be used in the dental industry for many years.. The product must be handled by a dentist professional according with the instructions and Matcrial Safety Data Sheet, wearing gloves, avoiding contact with skin, tissue gum and cycs using normal safe practices in a highly professional manner.
1
AMERICAN DENTAL PRODUCTS
More informations regarding the safety of the product are covered in the Material Safety Data Sheet for American Dental Products 113-35 Desensitizer with Fluoride, which copy please find enclosed.
Please be advised that our product American Dental Products HB-35 Desensitizer with Fluoride is not available on the market as of today, November 12, 1997, yet but we plan to market the product soon.
The descriptive information presented here satisfy the requirements of the SMDA of 1990.
Sincerely Yours,
George Nilitoz
George Nicolac. President and Official Correspondent AMERICAN DENTAL PRODUCT'S INC.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of a human face or profile.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. George Nicolae ·President American Dental Products, Incorporated 22 W 246 Sunnyside Road Medinah, Illinois 60157-9705
- NOV 1 4 1997
Re: K973185 American Dental Products HB-35 Desensitizer Trade Name: With Fluoride Regulatory Class: II Product Code: KLE Dated: Auqust 20, 1997 Received: Auqust 25, 1997
Dear Dr. 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, Drug, 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
3
Page 2 - Dr. Nicolae
through 542 of the Act for devices under the Electronic enrough State on the notrol provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as info reed in your 510 (k) premarket notification. The FDA asboing 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on compriation 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
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510(k) Number (if kn >wn):____________________________________________________________________________________________________________________________________________________ - K 973185 Device Name: _ HB-31 DE SE N S T T ZE WITH Indications For Use:
HB-35 DESENSITIZER U SE WITH FLUORIDE FOR SENSITIVE
(PLEASE DO NOT WR TE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number 1973185
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)