K Number
K012734
Device Name
CLEARFIL NEW BOND
Date Cleared
2001-09-14

(31 days)

Product Code
Regulation Number
872.3200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CLEAFIL NEW BOND is indicated for the following applications: 1) A dentin and enamel bonding system for composite resin restoration 2) A dentin and enamel bonding system for amalgam restoration
Device Description
CLEARFIL NEW BOND is classified into Resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling. Normally composite resins and amalgams are used as filling material for this purpose.
More Information

Not Found

No
The document describes a chemical bonding agent and does not mention any computational or analytical capabilities, let alone AI/ML.

No
The device is a bonding agent used to improve the retention of dental restorations, not to treat or cure a disease or condition. Its classification as a "Resin tooth bonding agent" further supports this.

No

This device is a resin tooth bonding agent used to improve the retention of dental restorations, not to diagnose a condition. Its classification (CFR 21 Section 872.3200) also indicates it's a bonding agent for teeth.

No

The device description explicitly states it is composed of materials like 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 use is for bonding composite resin and amalgam restorations to teeth. This is a direct application within the body (or on a part of the body, the tooth) for a restorative purpose.
  • Device Description: The device description clearly states it's a "Resin tooth bonding agent" intended to be painted on the interior of a prepared cavity of a tooth. This is a material applied to the tooth structure.
  • Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of such specimens.

The classification under CFR 21 Section 872.3200 (Resin tooth bonding agent) further confirms its classification as a dental device, not an IVD.

N/A

Intended Use / Indications for Use

CLEAFIL NEW BOND is indicated for the following applications:

    1. A dentin and enamel bonding system for composite resin restoration
  • A dentin and enamel bonding system for amalgam restoration 2)

Product codes

KLE

Device Description

CLEARFIL NEW BOND is classified into Resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling. Normally composite resins and amalgams are used as filling material for this purpose.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

tooth

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

Not Found

Key Metrics

Not Found

Predicate Device(s)

K943167

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

DICAL INC.

Image /page/0/Picture/2 description: The image is a black and white logo for Kuraray. The logo features a stylized letter "K" that is formed by a combination of straight and curved lines. The word "KURARAY" is printed in a simple sans-serif font below the letter "K". The logo is simple and modern.

tal Material Department Chome, Umeda, Kita-ku, Osaka 530-8611, JAPAN +81-6-348-2603 Facsimile: +81-6-348-2552

SEP 1 4 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 August 9, 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 NEW 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.

(K943167) CLEARFIL NEW BOND by Kuraray Co., Ltd. 1.

4. Description for the premarket notification

CLEARFIL NEW BOND is classified into Resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling. Normally composite resins and amalgams are used as filling material for this purpose.

1

5. Statement of the intended use

The intended uses of this device are as follows. They are completely the same as CLEARFIL NEW BOND manufactured by Kuraray Co., Ltd. (K943167).

  • A dentin and enamel bonding system for composite resin restoration 1)
  • A dentin and enamel bonding system for amalgam restoration 2)

6. Statement of the technological characteristics and safety

This device is essentially the same as CLEARFIL NEW BOND manufactured by Kuraray Co., Therefore the technological characteristics, chemical ingredients and safety of Ltd. (K943167). this device are completely the same as CLEARFIL NEW BOND.

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. In the center of the circle are three stylized human profiles facing to the right, with flowing lines representing hair or clothing.

SEP 1 4 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: K012734

Trade/Device Name: Clearfil New Bond Regulation Number: 872.3200 Regulation Name: Resin-Based Dental Adhesive System Regulatory Class: II Product Code: KLE Dated: August 9, 2001 Received: August 14, 2001

Dear Mr. Sasaki:

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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinently, or to are road Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions 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 (1 mr.), it is a 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.

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. of the rect or unly 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 and ilouing (21 cert forth in the quality systems (QS) regulation (21 CFR Part 820); and if roquirelients as lectronic 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) rms reter wrification. 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.

les Alatort

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

Enclosure

4

[CLEARFIL NEW BOND, Kuraray Medical Inc.]

K012734

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: CLEARFIL NEW BOND

Indications for Use

CLEAFIL NEW BOND is indicated for the following applications:

    1. A dentin and enamel bonding system for composite resin restoration
  • A dentin and enamel bonding system for amalgam restoration 2)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Part 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Susan Runner

(Division Sign-Off) (Division Sign-On)
Division of Dental, Infection Control,
Division of Dental, Infection Devices Division oral Hospital De 510(k) Number -