(42 days)
Not Found
Not Found
No
The summary describes a dental bonding agent and does not mention any AI or ML capabilities.
No
The device is described as a bonding agent for restorative dentistry, used for bonding materials like composite or amalgam to dental structures. It does not exert any therapeutic action on the body.
No
The device is described as a bonding agent for restorative dentistry, not for diagnosing conditions.
No
The device description and intended use clearly describe a bonding agent used in restorative dentistry, 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 bonding in restorative dentistry, specifically for bonding to dentin, enamel, porcelain, metal, and for composite repair. This is a direct application within the body (or on materials that will be placed in the body) for treatment purposes.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. The device described does not perform such tests.
- Anatomical Site: The anatomical site is Dentin and Enamel, which are parts of the tooth, not samples taken from the body for diagnostic testing.
The description clearly indicates a device used for a therapeutic or restorative purpose within the mouth, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
Use for almost all bonding needs in restorative dentistry. Ease of use and unsurpassed bond strength in a single syringe primer/ocnding resin makes PQ1 the agent of choice for most light cure bonding needs. Also use PQ1 with chemical sure luting and chemical cure composite (e.g. Permalute). PQ1 is conducive for bonding to:
- Dentin and Enamel i sing composite or amalgam
- Porcelain
- Metal
- Composite repair
Product codes
KLE
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
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
Prescription Use
§ 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 a human figure, represented by three curved lines that form the profile of a person's head and shoulders. The figure is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 3 0 1998
Mr. Scott E. Moore Vice President Operations Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095
K983668 Re : Modification of PQ1 Trade Name: Requlatory Class: II Product Code: KLE Dated: October 14, 1998 Received: October 19, 1998
Dear Mr. Moore:
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 legally marketed predicate 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 The general controls controls provisions of the Act. 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 Requlations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. 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
1
Page 2 - Mr. Moore
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 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral 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/dsma/dsmamajn.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
2
| 510(k) Number (if known): | Unknown |
|---|---|
| Device Name: | PO1 |
Indications For Use:
Use for almost all bonding needs in restorative dentistry. Ease of use and unsurpassed bond strength in a single syringe primer/ocnding resin makes PQ1 the agent of choice for most light cure bonding needs. Also use PQ1 with chemical sure luting and chemical cure composite (e.g. Permalute). PQ1 is conducive for bonding to:
-
- Dentin and Enamel i sing composite or amalgam
-
- Porcelain
-
- Metal
-
- Composite repair
(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) |
OR
Sandra L Shire for MSR
Over-The-Counter Use
(Optional Format 1-2-9
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_K 983668
Hospital Devices
Number K483669