(46 days)
Not Found
PQ1
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 used in restorative dentistry, which facilitates the adhesion of dental materials. It does not treat or prevent a disease or condition, nor does it affect the structure or function of the body in a therapeutic manner.
No
The device description indicates it is a "Single Syringe Bonding Agent" used for "bonding needs in restorative dentistry." Its functions are related to adhesion, not diagnosis.
No
The device description clearly identifies it as a "Single Syringe Bonding Agent," 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 chemical cure luting and composites, and bonding to various dental materials (dentin, enamel, porcelain, metal, composite). This is a direct application within the patient's mouth for dental restoration.
- Device Description: It's a bonding agent, a material used in dental procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVDs are used outside the body to analyze samples for diagnostic purposes. This device is used inside the body during a dental procedure.
N/A
Intended Use / Indications for Use
Use for almost all bonding needs in restorative dentistry. Chemical cure luting and chemical cure composites, namely PermaFlo DC, also bonds to light cured PQ1. PQ1 is conducive for bonding to:
- Dentin and Enamel using composite or amalgam
- Porcelain
- Metal
- Composite repair
Product codes
KLE
Device Description
PQ1 Single Syringe Bonding Agent
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dentin, 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/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white and appears to be from a scanned document.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Markus Gee Regulatory Affairs Manager Ultradent Products. Incorporated 505 West 10200 South . . South Jordan, Utah 84095
Re: K023042
Trade/Device Name: PQ1® Single Syringe Bonding Agent Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: September 09, 2002 Received: September 12, 2002
Dear Mr. Gee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
Page 2 - Mr. Markus Gee
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ukstowski
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| 510(k) Number (if known): | KO23042 |
|---|---|
| --------------------------- | --------- |
PO1 Single Syringe Bonding Agent Device Name:
Indications For Use:
Use for almost all bonding needs in restorative dentistry. Chemical cure luting and chemical cure composites, namely PermaFlo DC, also bonds to light cured PQ1. PQ1 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)
Prescription Use_ (Per 21 CFR 801.109 OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96
Suam Kury
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: