(70 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 description focuses on a chemical etching process for detecting decay.
No.
The device is used to detect residual decay, which is a diagnostic function, not a therapeutic one. It assists in a procedural technique rather than directly treating a condition.
Yes
The device is used to "DETECT RESIDUAL DECAY" which is a form of diagnosis in the context of dental care.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components. The intended use describes a technique involving etching dentine, which typically involves physical materials and tools, but the summary doesn't clarify if the device is the etching material itself, a software tool to guide the process, or something else entirely.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "DETECT RESIDUAL DECAY (DENATURED PROTEIN) WHILE ETCHING DENTINE". This is a diagnostic function, but it's performed in vivo (within the patient's mouth) during a dental procedure, not in vitro (outside the body, typically on a sample).
- Anatomical Site: The anatomical site is "Dentine", which is part of the patient's tooth.
- Lack of mention of samples: There is no mention of analyzing biological samples (like blood, urine, tissue samples, etc.), which is a key characteristic of IVDs.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates directly on the patient's tooth during a procedure.
N/A
Intended Use / Indications for Use
USE ETCH-DETECT TO DETECT RESIDUAL DECAY (DENATURED PROTEIN) WHILE ETCHING DENTINE IN THE "TOTAL ETCH" TECHNIQUE.
Product codes (comma separated list FDA assigned to the subject device)
EBC
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dentine
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
§ 872.3765 Pit and fissure sealant and conditioner.
(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.
0
JUN 10 1999
UN 10 1999
merican Dental Products Inc.
603 B C
Bensenville,
Phone:
Fax:
Image /page/0/Picture/12 description: The image shows the logo for the Dental Manufacturers of America (DMA). The logo is in black and white. The letters "DMA" are in large, bold font, and the words "DENTAL MANUFACTURERS OF AMERICA" are in a smaller font below the letters.
603 B Country Club Drive Bensenville, IL 60106-1329, USA
630-238-0275 Phone: 800-846-7120 630-238-0276
Website: www.Amdental.com E-mail: George@AmDental.com
510 ( K ) SUMMARY: K 991099
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. However a mishandling of Phosphoric Acid Gel, if become in contact with eyes, will cause blindness. Wash immediately eyes with plenty of water and get immediate medical attention. The product must be handled by a dentist professional according with the instructions and Material Safety Data Sheet, wearing gloves, avoiding contact with skin, tissue gum and eyes using normal safe practices in a highly professional manner.
1
flore informations regarding the safety of the product are covered in the Material y Data Sheet for American Dental Products Etch-Detector, which copy please find enclosed -
Please be advised that our product American Dental Products Etch-Detect is not ailable on the market as of today, March 25, 1999, yet but we plan to market the
oroduct soon.
The descriptive information presented here satisfy the requirements of the SMDA
of 1990.
Sincerely Yours,
George Nirtog
George Nicolae, Ph.D. President and Official Correspondent AMERICAN DENTAL PRODUCTS INC.
Etchdet7
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 1999
George Nicolae, Ph.D. President and Official Correspondent American Dental Products, Incorporated 603 B Country Club Drive Bensenville, Illinois 60106-1329
Re : K991099 American Dental Products Etch-Detector Trade Name: II Requlatory Class: Product Code: EBC May 24, 1999 Dated: Received: May 28, 1999
Dear Dr. Nicolae:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the market the abreatially 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 be basyos of becting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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.
3
Page 2 - Dr. Nicolae
Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of 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) 594-4692. 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.fdaggov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
.
K 441044
Page _ of _
Image /page/4/Picture/2 description: This image contains information about a medical device. The 510(k) number, if known, is K991099. The device name is AMERICAN DENTAL PRODUCTS ETCH-DETECT.
Indications For Use:
USE ETCH-DETECT TO DE TECT RESIDVAL AROTEIN) WHILE ETCHIN. DECAY (DENATURED " TOTAL ETCH " TECHNIR DENTINE IN THE
(PLEASE DO NOT 'VRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Con(urrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96).
Susan Runne
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number ..