(21 days)
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No
The summary describes a dental etching product and does not mention any AI or ML capabilities.
No
The device is used for conditioning enamel and dentin in a dental restorative technique, preparing the surface for bonding agents and composite restorative material. It is a material used in a procedure, not a device that itself provides therapy.
No
Explanation: The device, Quadrant Total Etch, is used for conditioning enamel and dentin in dental restorative techniques prior to bonding. Its function is to create mechanical retention sites, not to diagnose a condition or disease.
No
The provided text describes a dental etching product, which is a chemical substance used in a dental procedure. There is no mention of software, digital components, or any technology that would classify it as a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a product used in a dental procedure to prepare tooth surfaces (enamel and dentin) for bonding restorative materials. This is a direct application to the patient's body (or a part of it) during a treatment procedure.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
The Quadrant Total Etch is a material applied to the patient's teeth during a dental procedure, not a device used to test a sample taken from the patient.
N/A
Intended Use / Indications for Use
Quadrant Total Etch is used in the dental adhesive restorative technique for conditioning of enamel and dentin following the so-called "total etch technique", prior to the use of a bonding agent such as Quadrant UniBond. With this technique, numerous sites for mechanical retention on micro-scale will be created, forming an excellent basis for the bonding agent to penetrate, seal off the enamel and dentin surface and bond the composite restorative material to the cavity wall.
Product codes
EBF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
enamel and dentin
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, composed of three curved lines, representing the department's mission of protecting the health of all Americans. The bird is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 1998 DEC
Mr. Bernard van Duijn Manging Technical Services Cavex Holland BV Harmenjansweg 19-21 P.O. Box 852 2003 RW Haarlem (Holland)
K984043 Re : Quadrant Total Etch Trade Name: Requlatory Class: II Product Code: EBF Dated: November 11, 1998 Received: November 13, 1998
Dear Mr. van Duijn:
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. A 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 requlation 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Paqe 2 - Mr. Van Duijn
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA deberibed in your blown, prvalence 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.fda,gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timoty A. Ulatowsk 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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KY84043
Page 1 of 1
Page 1 of 1
510(k) NUMBER (IF KNOWN): K98404
DEVICE NAME: Quadrant Total Etch
INDICATIONS FOR USE:
Quadrant Total Etch is used in the dental adhesive restorative technique for conditioning of enamel and dentin following the so-called "total etch technique", prior to the use of a bonding agent such as Quadrant UniBond. .
With this technique, numerous sites for mechanical retention on micro-scale will be created, forming an excellent basis for the bonding agent to penetrate, seal off the enamel and dentin surface and bond the composite restorative material to the cavity wall.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED. )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
ﻟﻤﺴﺘﻮ
OR Over-The-Counter-Use
Susan Run (Optional Format 1-2-96)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number