CLEARFIL AP-X PLT

K023002 · Kuraray Medical, Inc. · EBF · Oct 25, 2002 · Dental

Device Facts

• Record ID: K023002
• Device Name: CLEARFIL AP-X PLT
• Applicant: Kuraray Medical, Inc.
• Product Code: EBF · Dental
• Decision Date: Oct 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Class I, II, V restorations of posterior teeth 1) Class III, IV, V restorations of anterior teeth 2) 3) Cervical cavities or defects involving root surfaces

Device Story

CLEARFIL AP-X PLT is a composite resin restorative material used by dental professionals to restore carious or structural defects in teeth. The device is supplied in a pre-loaded tip (PLT) delivery system. It is applied by a dentist to the prepared tooth cavity to fill and restore the tooth structure. The material functions as a tooth-shade resin to provide aesthetic and functional restoration of anterior and posterior teeth. It benefits patients by repairing structural damage and addressing dental decay.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological and chemical similarity to the predicate device.

Technological Characteristics

Tooth-shade resin material composed of bisphenol A glycidylmethacrylate (Bis-GMA). Delivered via pre-loaded tip (PLT) system. Class II device under 21 CFR 872.3690.

Indications for Use

Indicated for Class I, II, V restorations of posterior teeth; Class III, IV, V restorations of anterior teeth; and cervical cavities or defects involving root surfaces.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Predicate Devices

• CLEARFIL AP-X (K012740)

Submission Summary (Full Text)

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OCT 2 5 2002

[CLEARFIL AP-X

Image /page/0/Picture/3 description: The image is a black and white logo for Kuraray. The logo features a stylized letter "K" that is also shaped like a square. Below the symbol is the word "KURARAY" in a bold, sans-serif font.

# KURARAY MEDICAL INC.

Dental Material Department 3-1-6 Nihonbashi, Chuo-ku, Tokyo 103-8254, Japan Tel : [phone] Fax : [phone]

# 510(k) SUMMARY

| 1. Submitter | |
|----------------------|--------------------------------------------------|
| 1) Name | KURARAY MEDICAL INC. |
| 2) Address | 1621 Sakazu, Kurashiki, Okayama 710-8622, Japan |
| 3) 1. Contact person | Koji Nishida |
| | Dental Material Department, Kuraray Medical Inc. |

Masaya Sasaki 2. Contact person in U.S.A. Kuraray America Inc. 101 East 52nd Street, 26th Floor New York, NY 10022 Telephone : [phone] (Ext.115) 1-(800)-879-1676 Facsimile : (212)-867-3543 4) Date August 25, 2002

#### 2. Name of Device

| 1) Proprietary Name | CLEARFIL AP-X PLT |
|------------------------|---------------------------------------------|
| 2) Classification Name | Tooth shade resin material (21CFR 872.3690) |
| 3) Common/Usual Name | Composite resin restorative |

- 3. Predicate device:
The predicate device is as follow.

1. CLEARFIL AP-X by Kuraray Medical Inc. (K012740)

- 4. Description for the premarket notification
This product is classified into Tooth shade Resin Material, CFR 29 Section 872.3690, because it is a device composed of materials such as bisphenol A glycidylmethacrylate (Bis-GMA) intended to restore carious or structural defects in teeth.

#### 5. Statement of the intended use

The intended uses of this device are as follows. They are the same as CLEARFIL AP-X manufactured by Kuraray Medical Inc. (K012740).

- Class I, II, V restorations of posterior teeth 1)
- Class III, IV, V restorations of anterior teeth 2)
- 3) Cervical cavities or defects involving root surfaces

6. Statement of the technological characteristics and safety

This device is substantially same to CLEARFIL AP-X manufactured by Kuraray Medical Inc. (K012740). Therefore CLEARFIL AP-X and CLEARFIL AP-X PLT are substantially equivalent on the technological characteristics, chemical ingredients and safety.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

OCT 2 5 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kuraray Medical, Incorporated C/O Ms. Masaya Sasaki Kuraray America, Incorporated 101 East 52nd Street, 26th Floor New York, New York 10022

Re: K023002

Trade/Device Name: CLEARFIL AP-X PLT Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth-Shade Resin Material Regulatory Class: II Product Code: EBF Dated: September 04, 2002 Received: September 09, 2002

Dear Ms. 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 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.

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.

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#### Page 2 - Ms. Masaya Sasaki

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 (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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Timot 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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KO23002 510(k) Number (if known): .

Device Name: CLEARFIL AP-X PLT

# Indications for Use

CLEARFIL AP-X PLT is indicated for the following applications:

1) Class I, II, V restorations of posterior teeth

- 2) Class III, IV, V restorations of anterior teeth
3) Cervical cavities or defects involving root surfaces

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use______________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

La Aulhuts

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