(48 days)
Not Found
Gluma One Bond, Clearfil SE Bond, Optibond Solo
No
The document describes a chemical bonding agent and does not mention any computational or analytical capabilities that would involve AI/ML.
No.
The device is a dentin bonding agent and cavity sealant used for dental restorations and treating hypersensitive exposed root surfaces, primarily functioning as a material to aid in procedures rather than directly administering or producing a therapeutic effect itself.
No
The device description indicates it is a "dentin-bonding system" used with restorative materials and for treating hypersensitive areas. These are therapeutic and restorative applications, not diagnostic ones.
No
The device description clearly indicates it is a "single-bottle, light cured, dentin-bonding system" which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The described device is a dentin bonding agent. Its function is to bond restorative materials to tooth structure. This is a direct application to the patient's body (the tooth) and does not involve testing samples taken from the body.
- Intended Use: The intended uses clearly describe applications within the mouth for dental restoration and treatment of hypersensitivity, not for diagnostic testing of biological samples.
Therefore, this device falls under the category of a dental device used for treatment and restoration, not an IVD.
N/A
Intended Use / Indications for Use
This material is indicated for the following: Indications for Use:
- A dentin bonding agent used with direct filling materials that include but may not be limited to, composite resins, resin modified glass ionomers or compomers, etc.
- A dentin bonding agent used with resin cements or composite luting agents to retain indirect tooth-colored restorations that include but may not be limited to indirect composite or porcelain inlays and onlays, lamin veneers, either resin or porcelain, etc.
- Treatment of hypersensitive areas of exposed root surfaces.
- A cavity sealant applied to exposed dentin that has been prepared to receive a laboratory fabricated restoration such as porcelain-fused-to-metal crowns, cast alloy inlays or onlays, etc.
Product codes
KLE
Device Description
"TO BE NAMED" may be described as a single-bottle, light cured, dentin-bonding system especially formulated for use with resin composite restorative materials. The material is self-etching and does not require acid etching of tooth surfaces. It will also reliably bond to properly prepared porcelain or alloy surfaces that are free of contamination.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
Gluma One Bond, Clearfil SE Bond, Optibond Solo, et al.
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
FEB 7 2000
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
994302
510(k) SUMMARY
| Submitter: | Parkell, 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: | 14 December 1999 |
| Trade Name: | Currently Not Available |
| Common Name: | Dentin Bonding System |
| Classification Name: | Resin Tooth Bonding Agent |
| Equivalence: | Gluma One Bond, Clearfil SE Bond, Optibond Solo, et al. |
| Description/Intended Use: | "TO BE NAMED" may be described as a single-bottle, light
cured, dentin-bonding system especially formulated for use with
resin composite restorative materials. The material is self-etching
and does not require acid etching of tooth surfaces. It will also
reliably bond to properly prepared porcelain or alloy surfaces that
are free of contamination. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. The text is in all capital letters and is evenly spaced around the curve.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 2000 FEB
Mr. Nelson J Gendusa, D.D.S. Director of Research Parkell, Incorporated 155 Schmitt Boulevard Farmingdale, NY 11735
Re : K994302 PARKELL RESIN TOOTH BONDING AGENT Trade Name: Requlatory Class: II Product Code: KLE December 17, 1999 Dated: Received: December 21, 1999
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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. ನ್ನಡ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug 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 not affect any
2
Page 2 - Dr. Gendusa
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 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 regulation 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.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows a sequence of alphanumeric characters in a bold, sans-serif font. The characters are 'K994302', and they appear to be handwritten or stylized. The black characters are set against a white background, creating a high contrast.
Page 1 of I
K994307 510(k) Number (if known):
Device Name: _ "TO BE NAMED"
This material is indicated for the following: Indications for Use:
- A dentin bonding agent used with direct filling materials that include but may not be limited to, composite
resins, resin modified glass ionomers or compomers, etc.
- A dentin bonding agent used with resin cements or composite luting agents to retain indirect tooth-colored
restorations that include but may not be limited to indirect composite or porcelain inlays and onlays, lamin
veneers, either resin or porcelain, etc.
-
Treatment of hypersensitive areas of exposed root surfaces.
-
A cavity sealant applied to exposed dentin that has been prepared to receive a laboratory fabricated
restoration such as porcelain-fused-to-metal crowns, cast alloy inlays or onlays, etc.
- PRESCRIPTION DEVICE
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devi 510(k) Number