(33 days)
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Not Found
No
The summary describes a dental composite filling material and does not mention any AI or ML components or functionalities.
Yes
The device is a dental composite filling material used for the restoration of decayed teeth, which is a therapeutic intervention.
No
Explanation: The device is described as a "light curing dental composite filling material used in the adhesive restorative technique for the restoration of decayed teeth." It is used for filling, not for diagnosing.
No
The device is described as a "light curing dental composite filling material," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for restoring decayed teeth using a light-curing dental composite filling material. This is a direct treatment applied to the patient's tooth.
- Device Description: It's described as a "light curing dental composite filling material." This is a material used in a clinical procedure, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information about a patient's health.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a restorative material used directly on the tooth.
N/A
Intended Use / Indications for Use
Quadrant Postericr Dense is a light curing dental composite filling material used in the adhesive restc rative technique for the restoration of decayed teeth. Cavity preparation is performed according to the principles of adhesive dentistry, adopting the minir al invasive technique for maximal preservation of sound tooth tissue.
Quadrant Posterior Dense is specifically designed for the restoration of posterior teeth, using the same application instruments and techniques as for dental amalgam.
Product codes
EBF
Device Description
Quadrant Posterior Dense is a light curing dental composite filling material used in the adhesive restc rative technique for the restoration of decayed teeth.
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
posterior teeth
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight. The logo is black and white.
DEC 1 6 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Bernard van Duijn Manging Technical Services Cavex Holland BV Harmenjansweg 19-21 P.O. Box 852 2003 RW Haarlem (Holland)
Re : K984044 Trade Name: Quadrant Posterior Dense Regulatory Class: II Product Code: EBF Dated: November 11, 1998 November 13, 1998 Received:
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 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Van Duijn
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 leqally 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 Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) NUMBER (IF KNOWN): K984044
DEVICE NAME: Quadrant Posterior Dense
INDICATIONS FOR USE:
Quadrant Postericr Dense is a light curing dental composite filling material used in the adhesive restc rative technique for the restoration of decayed teeth. Cavity preparation is performed according to the principles of adhesive dentistry, adopting the minir al invasive technique for maximal preservation of sound tooth tissue.
Quadrant Posterior Dense is specifically designed for the restoration of posterior teeth, using the same application instruments and techniques as for dental amalgam.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED. )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 8(1.109)
Over-The-Counter-Use (Optional Format 1-2-96)
Susan Rumm
OR
(Division Sign-Off) Division of Dental, Infection Control. and General Hospital Devices 510(k) Number