PANAVIA F 2.0

K032455 · Kuraray Medical, Inc. · EMA · Nov 7, 2003 · Dental

Device Facts

• Record ID: K032455
• Device Name: PANAVIA F 2.0
• Applicant: Kuraray Medical, Inc.
• Product Code: EMA · Dental
• Decision Date: Nov 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2

Intended Use

Cementation of metal crowns and bridges, inlays and onlays. Cementation of porcelain crowns, inlays, onlays and veneers. Cementation of composite resin crowns, inlays and onlays. Cementation of adhesion bridges. Cementation of endodontic cores and prefabricated posts. Amalgam bonding.

Device Story

PANAVIA F 2.0 is a dental adhesive cement used by dentists for permanent cementation of various dental restorations (crowns, bridges, inlays, onlays, veneers, posts) and amalgam bonding. Composed of dimethacrylate monomers and inorganic fillers; applied by clinician in dental office setting. Device functions as a restorative material to secure prosthetics to tooth structure. Improved light-curing properties compared to predecessor; complies with ISO 4049:2000 standards. Benefits include enhanced clinical handling and polymerization performance during restorative procedures.

Clinical Evidence

Bench testing only. Performance evaluated against ISO 4049:2000 standards. Metrics included depth of cure, thickness of surface unpolymerized layer, and sensitivity to ambient light. Results demonstrated superior light-curing properties compared to the predicate device.

Technological Characteristics

Dental cement composed of dimethacrylate monomers and inorganic fillers. Complies with ISO 4049:2000. Light-curing material. Form factor is a dental adhesive system. No software or electronic components.

Indications for Use

Indicated for dental patients requiring cementation of metal, porcelain, or composite resin crowns, bridges, inlays, onlays, and veneers; adhesion bridges; endodontic cores and prefabricated posts; and amalgam bonding.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Predicate Devices

• PANAVIA F (K012432)
• CLEARFIL SE BOND (K012442)

Submission Summary (Full Text)

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NOV = 7 2003

K032455

[PANAVIA F 2.0, Kuraray Medical Inc.]

## 510(k) SUMMARY

| 1. Submitter | |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Name | KURARAY MEDICAL INC. |
| 2) Address | 1621 Sakazu, Kurashiki, Okayama 710-8622, Japan |
| 3) Contact person | Masaya Sasaki<br>Dental Material Division |
| 4) Date | August 8, 2003 |
| 5) Contact person in U.S.A. | Satoshi Yamaguchi<br>Kuraray America, Inc.<br>101 East 52nd Street, 26th Floor, New York, NY 10022<br>Telephone : [phone] (Ext.115)<br>Facsimile : (212)-867-3543 |

#### 2. Name of Device

| 1) Proprietary Name | PANAVIA F 2.0 |
|------------------------|--------------------------------|
| 2) Classification Name | Dental Cement (21CFR 872.3200) |
| 3) Common/Usual Name | Dental Adhesive |

#### 3. Predicate device:

The predicate devices are as follows.

| 1. | PANAVIA F | by Kuraray Medical Inc. | (K012432) |
|----|------------------|-------------------------|-----------|
| 2. | CLEARFIL SE BOND | by Kuraray Medical Inc. | (K012442) |

#### 4. Description for the premarket notification

PANAVIA F 2.0 is classified into dental cement, CFR 21 Section 872.3275, because it is a device composed of materials such as dimethacrylate monomers and inorganic fillers intended to be used for cementation of dental devices such as crown and bridges.

#### 5. Statement of the intended use

The intended uses of this device are as follows. They are completely the same as PANAVIA F manufactured by Kuraray Medical Inc. (K012441).

- 1) Cementation of metal crowns and bridges, inlays and onlays
- 2) Cementation of porcelain crowns, inlays, onlays and veneers
- 3) Cementation of composite resin crowns, inlays and onlays
- 4) Cementation of adhesion bridges
- 5) Cementation of endodontic cores and prefabricated posts
- 6) Amalgam bonding

#### 6. Statement of the technological characteristics and safety

- 6-1. Technological characteristics
This device is improved from PANAVIA F and complies with the requirement of ISO 4049:2000. The light curing times of this device was assigned according to the type of dental curing lights. Depth of cure, thickness of surface unpolymerized layer, and sensitivity to ambient light were measured and form the result of these tests, light curing properties of this

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device are superior to PANAVIA F.

### 6-2. Safety

All the ingredients of this device have been used the predicate devices, PANAVIA F and CLEARFIL SE BOND. Therefore the safety of this device is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is enclosed within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 7 2003

Kuraray Medical, Incorporated C/O Mr. Satoshi Yamaguchi Marketing Manager Kuraray America. Incorporated 101 East 52nd Street, 26th Floor New York, New York 10022

Re: K032455

Trade/Device Name: Panavia™ F 2.0 Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: October 31, 2003 Received: October 31, 2003

Dear Mr. Yamaguchi:

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.

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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 (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). 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) 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Susa Runoe
Q. Chi-S. Lin, Ph.D.

Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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(Premarket Notification [510(k)] Number) 510(k) Number (if known):

14032455

Device Name: PANAVIA F 2.0

# Indications for Use

PANAVIA F 2.0 is indicated for the following applications:

- Cementation of metal crowns and bridges, inlays and onlays. 1)
- 2) Cementation of porcelain crowns, inlays, onlays and veneers.
- 3) Cementation of composite resin crowns, inlays and onlays
- Cementation of adhesion bridges 4)
- 5) Cementation of endodontic cores and prefabricated posts
- 6) Amalgam bonding

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

| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
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Prescription Use (Part 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Susa Rums

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

510(k) Number: