(63 days)
Prime & Bond 2.1, Clearfil Liner Bond 2, Optibond, Syntac
Not Found
No
The summary describes a chemical bonding agent and does not mention any computational or data-driven features.
No
The device is a bonding agent used to seal dentinal tubules and aid in the retention of dental materials. While it addresses hypersensitivity, its primary function is not to treat a disease or condition in a therapeutic manner but rather to facilitate dental restorations.
No
The device is described as a tooth-bonding agent and dentin bonding system, used for sealing dentinal tubules and aiding in the retention of restorative materials. Its function is to treat and bond, not to identify or diagnose a condition.
No
The device description clearly states it is a "single-bottle, light-cured, dentin bonding system," which is a physical substance (a chemical formulation) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a product applied to the tooth for bonding and reducing sensitivity. This is a direct application to a biological structure, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The description confirms it's a bonding system for use with restorative materials and metallic surfaces. This aligns with a dental material used in treatment, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely therapeutic and restorative in a dental context.
N/A
Intended Use / Indications for Use
For use as a tooth-bonding agent that seals patent dentinal tubules to reduce hypersensitivity and aids in the retention of tooth-colored dental to reduce hypersenstering into are over EASY BOND that has been painted onto prepared cavities.
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
EASY BOND may be described as a single-bottle, light-cured, dentin bonding system especially formulated for use with resin composite restorative materials. It will also create reliable bonds properly prepared metallic surfaces that are free from contamination. EASY BOND is recommended on moist dentin substrates that have had any smear layer removed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth / 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Prime & Bond 2.1, Clearfil Liner Bond 2, Optibond, Syntac
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) SUMMARY
AUG 2 9 1997
| Submitted By: | Parkell Products Inc. |
|---|---|
| 155 Schmitt Blvd. | |
| Box 376 | |
| Farmingdale, NY 11735 | |
| TEL: 516-249-1134 | |
| FAX: 516-249-1242 | |
| Contact: | Nelson J. Gendusa, DDS |
| Director of Research | |
| Parkell | |
| 155 Schmitt Blvd. | |
| Box 376 | |
| Farmingdale, NY 11735 | |
| Submission Date: | 23 June 1997 |
| Trade Name: | EASY BOND |
| Common Name: | Dentin Bonding System |
| Classification Name: | Tooth Bonding Agent |
| Equivalence: | Prime & Bond 2.1, Clearfil Liner Bond 2, Optibond, Syntac |
| Description/Intended Use: | EASY BOND may be described as a single-bottle, light-cured, |
| dentin bonding system especially formulated for use with resin | |
| composite restorative materials. It will also create reliable bonds | |
| properly prepared metallic surfaces that are free from | |
| contamination. EASY BOND is recommended on moist dentin | |
| substrates that have had any smear layer removed. |
The above-cited material contains ingredients that are common in dental resins and bonding agents, and pose no health hazard when used according to directions. Use of resinous materials may be contraindicated in persons with known acrylate and/or methacrylate and/or hypersensitivities. The material herein described is polymerizable with currently available visible light curing devices.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nelson J. Gendusa, DDS Director of Research Parkell Products, Incorporated 155 Schmitt Boulevard Farmingdale, New York 11735
AUG 2 9 1007
Re : K972421 Easy Bond Trade Name: Regulatory Class: II Product Code: KLE Dated: June 23, 1997 Received: June 24, 1997
Dear Dr. Gendusa:
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, labeling, and prohibitions aqainst 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
2
Paqe 2 - Dr. Gendusa
through 542 of the Act for devices under the Electronic emough 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 diaqnostic 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 Office of Compriance at (30%) 33 100% - 100% - 100% per 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.gov/cdrh/dsmamain.html".
Sincerely yours
Ws. Calabrese
Timothy A. Ulatowsk Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
| 510(k) Number (if known): | K972421 |
|---|---|
| --------------------------- | --------- |
Device Name:
EASY BOND
1300
Indications For Use: :
For use as a tooth-bonding agent that seals patent dentinal tubules to reduce hypersensitivity and aids in the retention of tooth-colored dental to reduce hypersenstering into are over EASY BOND that has been painted onto prepared cavities.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner
(Division Sign-Of Division of Dental, and General Hospita 5,10(k) Numbar
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)