(148 days)
Not Found
Not Found
No
The provided text describes a dental adhesive with various bonding applications. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses solely on the chemical and functional properties of the adhesive.
No
The device is described as a bonding system and its uses are primarily for dental restorations and desensitization, which are not considered therapeutic interventions in the medical sense of treating a disease or condition.
No
The device is described as a bonding system and is used for restorations, desensitization, and bonding, which are therapeutic or restorative functions, not diagnostic ones.
No
The intended use describes a bonding system, which is a physical material used in dental procedures. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed for Apex Universal Adhesive are all related to dental procedures performed directly on a patient's teeth and surrounding structures. These are applications within the body (in vivo), not tests performed on samples taken from the body (in vitro).
- Device Description: While the device description is "Not Found," the intended uses clearly define its function as a bonding agent for dental restorations and treatments.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information based on laboratory tests.
Therefore, Apex Universal Adhesive is a dental material used for therapeutic and restorative purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Apex Universal Adhesive is a single component bonding system for:
- Direct Restorations: to seal enamel / dentin prior to restoring with light-cure or self-cure composite material
- Indirect Restorations: bonding light-cured, self-cured or dual-cured composite cements or glass ionomer or resin-modified glass ionomer cements
- Bonding CEREC® restorations
- Desensitization: to treat hypersensitive and / or exposed root surfaces
- Desensitizing crown preparations
- Sealing preparations before placing amalgams
- Bonding crowns and bridges
- Bonding in posts and cores
- Bonding veneers
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
enamel / dentin, root surfaces
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
ood and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 10, 2013
Apex Dental Materials, Incorporated C/O Mr. Chris Kulton 330 Telser Road LAKE ZURICH IL 60047
Re: K131043
Trade/Device Name: Apex Universal Adhesive Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: June 10, 2013 Received: June 13, 2013
Dear Mr. Kulton:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
Page 2 - Mr. Kulton
or any Federal statutes and regulations administered by other Federal agencies. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mary S. Brunner -S
Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation · Center for Devices and Radiological Health
Enclosure
2
Indications for Use:
510(K) Number (if known):
1131043
Device name:
Apex Universal Adhesive
Apex Universal Adhesive is a single component bonding system for:
- Direct Restorations: to seal enamel / dentin prior to restoring with light-cure or self-cure . composite material
- Indirect Restorations: bonding light-cured, self-cured or dual-cured composite cements or . glass ionomer or resin-modified glass ionomer cements
- Bonding CEREC® restorations .
- Desensitization: to treat hypersensitive and / or exposed root surfaces .
- Desensitizing crown preparations .
- Sealing preparations before placing amalgams ●
- Bonding crowns and bridges .
- Bonding in posts and cores .
- Bonding veneers .
Andrew l. Steen -5
2013.09.10 14:03:39 -04'00'
Division Sign-Off) ivision of Anesthesiology, General Hospital nfection Control, Dental Devices
510(k) Number: K131043
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRL, Office of Device Evaluation (ODE)
Prescription use X (Per 21 CFR 801,109 OR
Over- The- Counter Use
(Optional Format 1-2-96)
Page 4 of 15
510K Submission for Apex Universal Adhesive Apex Dental Materials, 330 Telser Road Lake Zurich, IL 60047
CONFIDENTIAL