(76 days)
Not Found
Not Found
No
The summary describes a dental bonding system and does not mention any AI or ML related terms or functionalities.
No
The device is a bonding system used in restorative dentistry, which is a material used for adhesion, not a device designed to treat a disease or condition.
No
The PermaQuick Bonding System is described as being "used for 95% of bonding needs in restorative dentistry" and for "bonding to Dentin and Enamel using composite or amalgam, Porcelain, Metal, and Composite repair." This indicates its function is for treatment (bonding materials) rather than diagnosing conditions.
No
The device description is not found, but the intended use describes a "Bonding System" and "agent," which strongly suggests a physical material or kit, 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 used within the body) for treatment purposes.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease or condition, or to examine specimens taken from the human body.
- Anatomical Site: The anatomical sites mentioned (Dentin and Enamel) are parts of the human body, not specimens being tested in vitro.
IVDs are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on the physical process of bonding materials within the mouth for restorative purposes.
N/A
Intended Use / Indications for Use
PQ 1 PermaQuick Bonding System is used for 95% of bonding needs in restorative dentistry. PQ 1 is conducive for bonding to:
- Dentin and Enamel using composite or amalgam.
- Porcelain
- Metal
- Composite repair
Product codes
KLE
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dentin and Enamel
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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles suggesting care and support. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 9 1998
Mr. Chester McCoy Requlatory Affairs Manager Ultradent Products, Incorporated 505 W. 10200 South 84065 South Jordan, Utah
K974283 Re : Trade Name: PQ 1 Requlatory Class: II Product Code: KLE Dated: November 10, 1997 November 14, 1997 Received:
Dear Mr. McCoy:
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 reqistration, listing of devices, good manufacturing practice, labelinq, 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 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 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
1
Page 2 - Mr. McCoy
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.
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 requlation 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
Timothy A. Ulatowski
Directpr Divisibn of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
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C
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510(k) Number (if known):
Device Name: _PQ 1
Indications For Use:
PQ 1 PermaQuick Bonding System is used for 95% of bonding needs in restorative dentistry . Ease of use I Q 1 t offinaQuick Donaling Cycleral as PQ 1 the agent of choice for all light cure bonding needs. PQ 1 is conducive for bonding to:
-
- Dentin and Enamel using 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)
Susa Risser
Division Sign. Off.
(Division Sign-Off) Division of Dental. Infection Control, and General Hospital Devices 510(k) Number .
Prescription Use
(Per 21 CFR §01.109) Yes
OR
Over-The-Counter Use الم
(Optional Format 1-2-96)