(3 days)
Not Found
Not Found
No
The summary describes a dental adhesive and does not mention any AI or ML components or functionalities.
No
The device is described as a material for bonding and luting various dental materials to dentin and enamel, which aligns with restorative dentistry rather than directly treating a disease or condition.
No
The device description indicates its use for bonding and luting dental materials, which are restorative and procedural functions, not diagnostic ones. It does not mention detection, diagnosis, or assessment of a disease or condition.
No
The provided text describes a material (adhesion to dentin of polymeric filling materials) and its intended use in dental procedures. It does not describe a software 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 material used for bonding dental filling materials to teeth (dentin and enamel) and other dental materials (metals, porcelain, glass). This is a direct application within the body (in vivo), not a test performed on samples taken from the body (in vitro).
- Anatomical Site: The anatomical sites mentioned are Dentin and Enamel, which are parts of the tooth structure.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, disease, or congenital abnormality. This device's function is to facilitate the physical adhesion of dental materials, not to diagnose or provide information about a patient's health status based on a sample.
N/A
Intended Use / Indications for Use
Adhesion to Dentin Of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, sami precious, and non-precious alloys, porcelain and glass and luting of same to Dentin and Enamel.
Product codes
KLE
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
Dentin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three heads, each head represented by a simple, curved line.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 1997
Mr. Murray Gamberg Quality Systems Director Jeneric/Pentron, Incorporated 53 North Plains Industrial Road Wallingford, Connecticut 06492-0724
Re : K973388 Dentin Conditioning and Adhesive (Bond 1) Trade Name: Requlatory Class: II Product Code: KLE Dated: September 3, 1997 Received: September 9, 1997
Dear Mr. Gamberg:
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 of the Act. The general controls provisions 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 Regulations, Title 21, Parts 800 to 895. ਬ 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 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
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Page 2 - Mr. Gamberg
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 requlations.
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 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 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Patraici Cucainiffer
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
FDA/ODE/DDIGD
Page: _ _ _ _ _ _
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
| 510(k) Number (if known): | 1973388 |
|---|---|
| Device Name: | Bond 1 |
Indicanons For Use :
Indication for Use
Adhesion to Dentin Of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, sami precious, and non-precious alloys, porcelain and glass and luting of same to Dentin and Enamel.
CII. 6. 28. 10
(PLESASE DO NOT WRITE BELOW THE LINE - CONTINUE ON ANOTIBUR PAGE IP NEEDED)
Concernents of CDRH, Office of Dovice Evaluarion (ODE)
usar (Division Sign-Off) Division of Dental, Infection Control, and General Hospital I 510(k) Number .
Preseription List: (Fex 21 CPR 801 109)
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