(72 days)
Not Found
No
The description focuses on a chemical dye solution for staining dentin and does not mention any computational or algorithmic processes, let alone AI/ML.
No.
The device is described as a diagnostic aid that stains carious dentin to guide conservative caries removal, and it does not directly treat or cure a disease.
Yes
Explanation: The device is described as differentiating between infected and uninfected dentin to guide conservative caries removal, which is a form of diagnosis to inform treatment.
No
The device description clearly states it is a "water-soluble solution of dye in solvent," indicating it is a chemical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this product is a color-indicator applied directly to the dentin within the patient's mouth during a dental procedure. It's used in vivo (within the living body), not in vitro (in a test tube or other artificial environment).
- The purpose is to guide a procedure, not to diagnose a condition based on a specimen. While it helps the dentist differentiate between types of dentin, its primary function is to assist in the removal of carious tissue during a restoration, not to provide a diagnosis based on a laboratory analysis of a sample.
Therefore, this device falls under the category of a dental device used during a clinical procedure, not an IVD.
N/A
Intended Use / Indications for Use
For use as a color-indicator of caries demineralized dentin. The water-soluble dye differentiates between dentin infected by caries and uninfected demineralized dentin to serve as a guide for the dentist-user in caries restoration.
Product codes
LFC
Device Description
CARIES STAIN may be described as a water-soluble solution of dye in solvent that selectively stains carious, infected dentin. It differentiates between non-remineralizable and remineralizable dentin to serve as a guide for conservative caries removal while maintaining as much vital tooth structure as possible.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dentinal caries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentist-user
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)
KAR-D-TEK, CARIES DETECTOR, SEEK, CARIES FINDER, TEAM CARIES INDICATOR, PULPDENT SNOOP
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows a sequence of handwritten digits and letters. The sequence appears to be K973200. The characters are written in a simple, slightly rough style, giving them a casual appearance.
510(k) SUMMARY
NOV - 6 1997
| Submitter: | Parkell Products Inc.
155 Schmitt Blvd.
Box 376
Farmingdale, NY 11735
TEL: 516-249-1134
FAX: 516-249-1242 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Nelson J. Gendusa, DDS
Director of Research
Parkell
155 Schmitt Blvd.
Box 376
Farmingdale, NY 11735 |
| Submission Date: | 14 August, 1997 |
| Trade Name: | CARIES STAIN |
| Common Name: | Caries Indicator/Detector |
| Classification Name: | Caries Detection Device |
| Equivalence: | KAR-D-TEK; CARIES DETECTOR; SEEK; CARIES FINDER;
TEAM CARIES INDICATOR; PULPDENT SNOOP |
| Description/Intended Use: | CARIES STAIN may be described as a water-soluble solution of
dye in solvent that selectively stains carious, infected dentin. It
differentiates between non-remineralizable and remineralizable
dentin to serve as a guide for conservative caries removal while
maintaining as much vital tooth structure as possible. |
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nelson J. Gendusa, DDS Director of Research Parkell Products, Incorporated 155 Schmitt Boulevard Farmingdale, New York 11735
NOV - 6 1997
Re: K973200 Trade Name: Caries Stain Regulatory Class: II Product Code: LFC Dated: August 21, 1997 Received: Auqust 26, 1997
Dear Dr. Gendusa:
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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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
2
Page 2 - Dr. Gendusa
through 542 of the Act for devices under the Electronic chrough 542 or the not il provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acbeing of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marketed predication with 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) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact ene promotion and (301) 594-4639. Also, please note ene 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 J. Ulatowski
Timb Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
. Enclosure
3
510(k) Number (if known):
Device Name:
CARIES STAIN
Indications For Use:
For use as a color-indicator of caries demineralized dentin. The water-soluble dye differentiates between dentin infected by caries water-soluble dye differentates occa a guide for the dentist-user in and unancecco demir and be? (es as a games restoration.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rumsis
(Division Sign-Off Division of Dental and General Ho 510(k) Number
Prescription Use رسم (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)