K Number
K971733
Device Name
2 BOND 2
Date Cleared
1997-10-02

(146 days)

Product Code
Regulation Number
872.3200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The 2 bond 2 system is used for the seating of non-metal, laboratory fabricated restorations such as: Artglass, porcelain, ceramic and composite inlays, onlays, veneers, crowns, and bridges. 2 bond 2 is used for the seating of metal-supported, laboratory fabricated restorations such as: crowns, bridges, inlays/onlays Maryland bridges, brackets and splints.
Device Description
Not Found
More Information

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No
The provided text describes a dental bonding system and does not mention any AI or ML components or functionalities.

No
The device is used for "seating" dental restorations, which is a placement or bonding function, not a therapeutic treatment of a disease or condition.

No
The device, "2 bond 2 system," is described as being used for "seating of non-metal, laboratory fabricated restorations" and "seating of metal-supported, laboratory fabricated restorations." This indicates it is a material or system for bonding or attaching dental restorations, which is a treatment or restorative function, not a diagnostic one. There is no mention of identifying, analyzing, or determining the presence or nature of a disease or condition.

No

The intended use describes the seating of physical dental restorations, which are hardware. The device description is not available, but the intended use strongly suggests a physical component is involved in the seating process.

Based on the provided information, the 2 bond 2 system is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use describes the device as being used for the "seating of non-metal, laboratory fabricated restorations" and "seating of metal-supported, laboratory fabricated restorations". This clearly indicates a use in a dental or restorative procedure, which is performed in vivo (on a living organism).
  • 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, etc.) to provide information for diagnosis, monitoring, or treatment.

IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. The 2 bond 2 system's function is to bond dental restorations to teeth, which is an in vivo application.

N/A

Intended Use / Indications for Use

The 2 bond 2 system is used for the seating of non-metal, laboratory fabricated restorations such as: Artglass, porcelain, ceramic and composite inlays, onlays, veneers, crowns, and bridges. 2 bond 2 is used for the seating of metal-supported, laboratory fabricated restorations such as: crowns, bridges, inlays/onlays Maryland bridges, brackets and splints.

Product codes

KLE

Device Description

Not Found

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

Not Found

Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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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)

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Reference Device(s)

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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

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three lines extending from its head, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

OCT - 2 1997

Ms. Sharon Parker Requlatory Affairs Manager Heraeus Kulzer, Incorporated 10005 Muirlands Boulevard Irvine, California 92718-2595

Re : K971733 Trade Name: 2 Bond 2 Requlatory Class: II Product Code: KLE Dated: August 5, 1997 Received: August 7, 1997

Dear Ms. Parker:

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 reguirements 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 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 regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does

1

not affect any 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 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 diagnostic 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 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

2

INDICATIONS FOR USE

Page 1 of 1

510(k) Number: __ K97/733

2 bond 2 Device Name:

The 2 bond 2 system is used for the seating of non-metal, laboratory fabricated restorations such as: Artglass, porcelain, ceramic and composite inlays, onlays, veneers, crowns, and bridges.

2 bond 2 is used for the seating of metal-supported, laboratory fabricated restorations such as: crowns, bridges, inlays/onlays Maryland bridges, brackets and splints.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.

CONCURRENCE OF CHRD, OFFICE OF DEVICE EVALUATION (OED)

Susan Runner

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510/k) Number _

Prescription Use _ 14 (Per 21 CFR 801.109

OR

No Over-The Counter Use_