K Number
K012442
Device Name
MODIFICATION TO CLEARFIL SE BOND
Date Cleared
2001-09-10

(41 days)

Product Code
Regulation Number
872.3200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CLEAFIL SE BOND is indicated for the following applications: 1) Direct filling restorations using light-curing composite or compomer 2) Cavity sealing as a pretreatment for indirect restorations 3) Treatment of hypersensitive and/or exposed root surfaces 4) Intraoral repairs of fractured facing crowns made of porcelain, hybrid ceramics or composite resin using light-curing composite 5) Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin
Device Description
CLEARFIL SE BOND is classified into the resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials.
More Information

Not Found

No
The document describes a dental bonding agent and its intended uses, which are standard applications for this type of material. There is no mention of AI, ML, image processing, or any other technology that would suggest the incorporation of AI/ML. The device description focuses on the material composition and its function as a bonding agent.

No.
The device description indicates its purpose is to improve the retention of restorative materials in a tooth, not to provide therapeutic treatment.

No
The device is a bonding agent used to improve the retention of restorative materials, not to diagnose a condition.

No

The device description explicitly states it is a "resin tooth bonding agent" composed of "materials such as dimethacrylate monomers," which are physical substances, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended uses listed are all related to dental procedures performed directly on a patient's tooth (direct filling, cavity sealing, treating hypersensitivity, repairing crowns, surface treatment of prosthetic appliances). These are clinical applications, not laboratory tests performed on samples taken from the body.
  • Device Description: The device is described as a "resin tooth bonding agent" intended to be "painted on the interior of a prepared cavity of a tooth." This further reinforces its use in a clinical dental setting.
  • Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis, treatment, or prevention based on in vitro analysis.

Therefore, CLEARFIL SE BOND is a dental device used for bonding and restoration, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

CLEAFIL SE BOND is indicated for the following applications:

    1. Direct filling restorations using light-curing composite or compomer
    1. Cavity sealing as a pretreatment for indirect restorations
    1. Treatment of hypersensitive and/or exposed root surfaces
    1. Intraoral repairs of fractured facing crowns made of porcelain, hybrid ceramics or composite resin using light-curing composite
    1. Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin

Product codes (comma separated list FDA assigned to the subject device)

KLE

Device Description

CLEARFIL SE BOND is classified into the resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Tooth/teeth, cavity

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.

K990040

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

RARAY MEDICAL INC.

Image /page/0/Picture/2 description: The image is a black and white logo for Kuraray. The logo features a stylized letter "K" inside of a square. The word "KURARAY" is written in block letters below the square.

Dental Material Department Chome, Umeda, Kita-ku, Osaka 530-8611, JAPAN +81-6-348-2603 Facsimila- +81-6-348-2552

K012442

SEP 1 0 2001

510(k) SUMMARY

1. Submitter

    1. Name
  1. Date
    1. Address
    1. Contact person
  1. Contact person in U.S.A.

KURARAY MEDICAL INC. 1621 Sakazu, Kurashiki, Okayama 710-8622, Japan Koji Nishida DENTAL MATERIAL DEPARTMENT July 23, 2001 Masaya Sasaki 30th Fl. Metlife Building, 200 Park Avenue, New York, NY 10166 Telephone : (212)-986-2230 1(800)-879-1676 Facsimile : (212)-867-3543

2. Name of Device

1) Proprietary NameCLEARFIL SE BOND
2) Classification NameResin tooth bonding agent (21CFR 872.3200)
3) Common/Usual NameResin-based dental adhesive system

3. Predicate device:

Kuraray Co., Ltd. will transfer the medical device business and the relevant functions including manufacturing facilities to its subsidiary company named Kuraray Medical Inc. on The aim of 510(k) submission is to alter the name and address of October 1st 2001. manufacturer, and not to intend other changes.

The predicate device is as follow.

CLEARFIL SE BOND by Kuraray Co., Ltd. (K990040) 1.

4. Description for the premarket notification

CLEARFIL SE BOND is classified into the resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials.

1

    1. Statement of the intended use
      The intended uses of this device are as follows. They are completely the same as CLEARFIL SE BOND manufactured by Kuraray Co., Ltd. (K990040).
    1. Direct filling restorations using light-curing composite or compomer
    1. Cavity sealing as a pretreatment for indirect restorations
    1. Treatment of hypersensitive and/or exposed root surfaces
    1. Intraoral repairs of fractured facing crowns made of porcelain, hybrid ceramics or comosite resin using light-curing composite
    1. Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin
    1. Statement of the technological characteristics and safety

This device is essentially the same as CLEARFIL SE BOND manufactured by Kuraray Co., td. (K990040). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as CLEARFIL SE BOND.

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles or abstract shapes, possibly representing people or interconnectedness.

Public Health Service

SEP 1 0 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kuraray Medical Incorporated C/O Ms. Masaya Sasaki Kuraray America, Incorporated 30th Floor Metlife Building 200 Park Avenue New York, New York 10166

Re: K012442

Trade/Device Name: Modification To Clearfil SE Bond Regulation Number: 872.3200 Regulation Name: Resin-Based Dental Adhesive System Regulatory Class: II Product Code: KLE Dated: July 23, 2001 Received: July 31, 2001

Dear Ms. Sasaki:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because mined 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 mendments, or to devices that have been reclassified in accordance with the provisions of Anonoments, or to active and Cosmetic Act (Act) that do not require approval of a premarket the rouchal application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls 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 (1 wr ), it may of buryed in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in farther 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

3

Page 2 - Ms. Sasaki

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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (section 531-542 of the Act; 21); CFR 1000-1050.

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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 807.97). 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,

Timothy A. Ulatowski

Timothy A. Jlatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

[CLEARFIL SE BOND, Kuraray Medical Inc.]

K012442

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: CLEARFIL SE BOND

Indications for Use

CLEAFIL SE BOND is indicated for the following applications:

  • Direct filling restorations using light-curing composite or compomer 1)
  • Cavity sealing as a pretreatment for indirect restorations 2)
  • Treatment of hypersensitive and/or exposed root surfaces 3)
  • Intraoral repairs of fractured facing crowns made of porcelain, hybrid ceramics or composite 4) resin using light-curing composite
  • Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured 5) composite resin

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ V (Part 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

Russe

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

ADVIN