K Number
K032179
Device Name
COMP. E
Manufacturer
Date Cleared
2003-09-09

(57 days)

Product Code
Regulation Number
872.3200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For use in repairing, adding to, or otherwise modifying the surface of resins . Especially useful for enhancing co-polymentzation between an old and a new composite resin when the former requires refreshing or repair in clinical life. May also be used as the primer of indirect, resin-based restorations to enhance the bond of these with resin-based luting materials. This agent is also useful for bond of highly cross-inked denture teeth, acrylic or composite, to denture base resins, This material will improve the union between resin surfaces in a myriad of situations, both intra- and exta-orally.
Device Description
A light-cured, resin-based primer that is used to enhance the bond of old to new resin-based materials. The material is indicated for use on the intaglio of indirect composite restorations. It can be used to refresh the worn but otherwise intact surfaces of composite resin restorations.
More Information

NOT FOUND

Not Found

No
The 510(k) summary describes a light-cured, resin-based primer for dental applications. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text. The description focuses on the chemical and physical properties of the resin and its intended use in bonding dental materials.

No.
The device is described as a light-cured, resin-based primer used to enhance the bond between resin-based materials, primarily for dental restorations and repairs, which serves a material-preparation function rather than a direct therapeutic effect on a disease or condition.

No

The device is described as a light-cured, resin-based primer used to repair, add to, or modify the surface of resins, specifically to enhance co-polymerization or bond between resin-based materials. Its function is to improve material adhesion, not to diagnose medical conditions.

No

The device description clearly states it is a "light-cured, resin-based primer," indicating it 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/Indications for Use: The intended use describes a material for repairing, adding to, or modifying the surface of resins, primarily in dental applications (composite restorations, denture teeth, denture bases). This is a direct application to materials used in or on the body, not for testing samples taken from the body.
  • Device Description: The description reinforces its use as a light-cured, resin-based primer for enhancing bonds between resin materials. Again, this is a material applied to other materials, not a test performed on biological samples.
  • Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Detecting or measuring substances in biological samples
    • Providing information for diagnosis, monitoring, or screening of diseases or conditions.

The device is clearly intended for use in a clinical setting to improve the physical properties and bonding of dental and prosthetic materials. This falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

A light-cured, resin-based primer that is used to enhance the bond of old to new resin-based materials. The material is indicated for use on the intaglio of indirect composite restorations. It can be used to refresh the worn but otherwise intact surfaces of composite resin restorations.
For use in repairing, adding to, or otherwise modifying the surface of resins. Especially useful for enhancing co-polymentzation between an old and a new composite resin when the former requires refreshing or repair in clinical life. May also be used as the primer of indirect, resin-based restorations to enhance the bond of these with resin-based luting materials. This agent is also useful for bond of highly cross-inked denture teeth, acrylic or composite, to denture base resins, This material will improve the union between resin surfaces in a myriad of situations, both intra- and exta-orally.

Product codes

KLE, EBI

Device Description

A light-cured, resin-based primer that is used to enhance the bond of old to new resin-based materials.

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)

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

510(k) SUMMARY

| Submitter: | Parkell, Inc.
155 Schmitt Blvd.
Box 376
Farmingdale, NY 11735
TEL: 631-249-1134
FAX: 631-249-1242 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Nelson J. Gendusa, DDS
Director of Research
Parkell
155 Schmitt Blvd.
Box 376
Farmingdale, NY 11735 |
| Submission Date: | 15 April 2003 |
| Trade Name: | Currently Not Available |
| Common Name: | Resin Primer |
| Classification Name: | Material, Tooth Shade, Resin |
| Equivalence: | Special Bond and Special Bond II |
| Description/Intended Use: | A light-cured, resin-based primer that is used to enhance
the bond of old to new resin-based materials. The
material is indicated for use on the intaglio of indirect
composite restorations. It can be used to refresh the
worn but otherwise intact surfaces of composite resin
restorations. |

:

1

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes. The symbol is composed of curved lines and is positioned in the center of the circle.

Public Health Service

SEP - 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nelson J. Gendusa, DDS Director of Research Parkell, Incorporated 155 Schmitt Boulevard, Box 376 Farmingdale, New York 11735

Re: K032179

Trade/Device Name: Comp.E Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE and EBI Dated: July 09, 2003 Received: July 14, 2003

Dear Dr. Gendusa:

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.

2

Page 2 - Nelson J. Gendusa, DDS

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. 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 (OS) 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), 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) you may obtain. 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.

Susan Runner
Susan Runner, DDS, MA

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known):_

Device Name: _Comp. E

Indications for Use: For use in repairing, adding to, or otherwise modifying the surface of resins . Especially useful for enhancing co-polymentzation between an old and a new composite resin when the former requires refreshing or repair in clinical life. May also be used as the primer of indirect, resin-based restorations to enhance the bond of these with resin-based luting materials. This agent is also useful for bond of highly cross-inked denture teeth, acrylic or composite, to denture base resins, This material will improve the union between resin surfaces in a myriad of situations, both intra- and exta-orally.

Kai Mully for MSR

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number: K 032179