PANAVIA F

K983361 · Kuraray America, Inc. · EMA · Nov 13, 1998 · Dental

Device Facts

• Record ID: K983361
• Device Name: PANAVIA F
• Applicant: Kuraray America, Inc.
• Product Code: EMA · Dental
• Decision Date: Nov 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is used for cementation of dental devices such as crowns or bridges. The indication is same to that of dental cements as shown blow. 1) Cementation of metal crowns and bridges, inlays and onlays 2) Cementation of porcelain crowns, inlays and onlays. 3) Cementation of composite resin crowns, inlays and onlays 4) Cementation of adhesion bridges and splints 5) Cementation of metal cores and prefabrication posts 6) Bonded amalgam restorations

Device Story

PANAVIA F is a resin-based dental cement used by dentists for the permanent cementation of various dental restorations, including crowns, bridges, inlays, onlays, cores, and posts. The device consists of two pastes (A and B), ED Primer (liquids A and B), ALLOY PRIMER, and Oxyguard II. It functions via chemical and visible light-activated curing. The clinician applies the primer and cement to the dental device and the prepared tooth surface to facilitate adhesion. The device provides a stable, bonded interface between the restoration and the tooth structure, improving retention and marginal integrity. It is intended for professional use in a clinical dental setting.

Clinical Evidence

No clinical data provided; bench testing only. Substantial equivalence is based on chemical composition, intended use, and performance characteristics similar to predicate devices.

Technological Characteristics

Resin-based dental cement; dual-cure (chemical and visible light activation). Components include dimethacrylate monomers, inorganic fillers, ED Primer, ALLOY PRIMER, and Oxyguard II. Form factor is a multi-component paste/liquid system. No specific ASTM standards or connectivity features described.

Indications for Use

Indicated for cementation of metal, porcelain, and composite resin crowns, inlays, and onlays; adhesion bridges and splints; metal cores and prefabrication posts; and bonded amalgam restorations.

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 21 (K933030)
• VARIOLINK II (K971372)
• C&B META BOND (K960464)

Reference Devices

• PANAVIA EX (K855211)
• CLEARFIL LINERBOND 2V (K974486)
• CLEARFIL TEETHMATE F-1 (K965091)
• ALLOY PRIMER (K974089)
• DELTON PLUS (K951296)
• FLUOREVER PIT AND FISSURE SEALANT (K890494)

Submission Summary (Full Text)

{0}------------------------------------------------

# NOV 1 3 1998

Image /page/0/Picture/1 description: The image shows the text 'K983361' in a bold, sans-serif font. Below this text, there is the text '[PANAVIA F, Kuraray]' in a smaller font size. The text appears to be part of a document or label, possibly indicating a product code or reference.

Image /page/0/Picture/2 description: The image is a black and white logo for Kuraray. The logo features a stylized letter "K" with a smaller letter "G" nested inside it. Below the symbol, the word "KURARAY" is written in a bold, sans-serif font.

KURARA

12-39 1-Chome Umeda Kita-ku Osaka 530-86 Phone : [phone] Facsimile: [phone]

## 510(k) SUMMARY

#### 1. Submitter

| 1) Name | KURARAY CO., LTD. |
|-------------------|-----------------------------------------------------------------------------|
| 2) Address | 1-12-39, Umeda, Kita-ku, Osaka 530-8611, Japan |
| 3) Telephone | 81(Japan)-6-348-2603 |
| 4) Facsimile | 81(Japan)-6-348-2552 |
| 5) Contact person | Yoshinori Nagase<br>Dental Material Department<br>Medical Products Division |
| 6) Date | September 28, 1998 |

### 2. Representing (Subsidiary of KURARAY CO., LTD.)

| 1) Name | KURARAY AMERICA INC. |
|-------------------|-------------------------------------------------------|
| 2) Address | 30th FI. Metlife Building, 200 Park Avenue, New York, |
| | NY 10166 |
| 3) Telephone | (212)-986-2230 |
| 4) Facsimile | (212)-867-3543 |
| 5) Contact person | Koji Fujita |
| | President |

#### 3. Name of Device

| 1) Proprietary Name | PANAVIA F |
|------------------------|---------------------------------|
| 2) Classification Name | Dental Cement (21 CFR 872.3275) |
| 3) Common/Usual Name | Dental Adhesive |

#### 4. Predicate devices:

| 1. | PANAVIA 21 by Kuraray Co., Ltd. | (K933030) |
|----|--------------------------------------------|-----------|
| 2. | VARIOLINK II by Ivoclar North America Inc. | (K971372) |
| 3. | C&B META BOND by Perkell | (K960464) |

#### 5. Description for the premarket notification

PANAVIA F 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 crowns or bridges.

This product is similar and substantially equivalent in design, composition and function to dental cement of the products which are identified in the paragraph 4 of this summary; all of which are safe, effective and beneficial.

{1}------------------------------------------------

6. Statement of the intended use

This device is used for cementation of dental devices such as crowns or bridges. The indication is same to that of dental cements as shown blow.

| 1) | Cementation of metal crowns and bridges, inlays and onlays | |
|----|------------------------------------------------------------|-----------|
| 1. | PANAVIA 21 by Kuraray Co., Ltd. | (K933030) |
| 2. | C&B META BOND by Perkell | (K960464) |
| 2) | Cementation of porcelain crowns, inlays and onlays. | |
| 1. | PANAVIA 21 by Kuraray Co., Ltd. | (K933030) |
| 2. | VARIOLINK II by Ivoclar North America Inc. | (K971372) |
| 3) | Cementation of composite resin crowns, inlays and onlays | |
| 1. | PANAVIA 21 by Kuraray Co., Ltd. | (K933030) |
| 2. | VARIOLINK II by Ivoclar North America Inc. | (K971372) |
| 4) | Cementation of adhesion bridges and splints | |
| 1. | PANAVIA 21 by Kuraray Co., Ltd. | (K933030) |
| 2. | C&B META BOND by Perkell | (K960464) |
| 5) | Cementation of metal cores and prefabrication posts | |
| 1. | PANAVIA 21 by Kuraray Co., Ltd. | (K933030) |
| 6) | Bonded amalgam restorations | |
| 1. | PANAVIA 21 by Kuraray Co., Ltd. | (K933030) |

- 7. Statement of the technological characteristics and safety
PANAVIA F is modified in its components and chemical substances from those in PANAVIA 21 permitted to be marketed (K933030). These modifications do not affect the safety and effectiveness.

- 7-1 Technological characteristics
PANAVIA F is a resin based cement cured chemically and by visible light activation, and the improved device of PANAVIA 21. There are two major improvements; the curing method and introduction of the metal adhesion primer (ALLOY PRIMER, K974089). These improvements are not affect on the performance of PANAVIA 21

This device consists of Paste (A and B pastes), ED Primer (Liquids A and B), ALLOY PRIMER, Oxyguard II, and accessories. These components are similar to that of dental cements of the products as shown blow.

| 1. | PAÑAVIA 21 by Kuraray Co., Ltd. | (K933030) |
|----|-----------------------------------------|-----------|
| 2. | VARIOLINK II Ivoclar North America Inc. | (K971372) |
| 3. | C&B META BOND by Perkell | (K960464) |

{2}------------------------------------------------

The indication of PANAVIA F is same as those of the above devices sold in U.S. market. (The detail information is described in the paragraph 6 of this summary.) The usage of PANAVIA F is also similar to those of PANAVIA 21 used in conjunction with ALLOY PRIMER except the curing method. This device can be cured chemically and by visible light activation. The curing method is similar to that for PANAVIA 21 and VARIOLINK II.

Therefore, PANAVIA F is substantially equivalent in intended use and performance to that of products sold in the U.S. market.

#### 7-2 Chemical ingredients and safety

The chemical ingredients have been already used in the following products that is allowed to be sold in U.S. market. The safety of this material is substantially equivalent to predicate devices.

| 1. | PANAVIA 21 by Kuraray Co., Ltd. | (K933030) |
|----|---------------------------------------------------------|-----------|
| 2. | PANAVIA EX by Kuraray Co., Ltd. | (K855211) |
| 3. | CLEARFIL LINERBOND 2V by Kuraray Co., Ltd. | (K974486) |
| 4. | CLEARFIL TEETHMATE F-1 by Kuraray Co., Ltd. | (K965091) |
| 5. | ALLOY PRIMER by Kuraray | (K974089) |
| 6. | DELTON PLUS by Dentsply | unknown |
| 7. | FLUOREVER PIT AND FISSURE SEALANT by<br>Macrochem Corp. | (K890494) |

[Note]

DELTON PLUS is thought to be the same product as DELTON F (K951296).

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with three horizontal lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 1998

Kuraray Co., Ltd. C/O Mr. Koji Fujita President Kuraray America, Incorporated 30th FI Metlife Building 200 Park Avenue New York, New York 10166-3098

Re : K983361 Trade Name: PANAVIA F Regulatory Class: II Product Code: EMA September 24, 1998 Dated: September 24, 1998 Received:

Dear Mr. Fujita:

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 qeneral controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. ਸੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

{4}------------------------------------------------

Page 2 - Mr. Fujita

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 [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 ene regaration Chorosa, information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Tim Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

K98556|

Image /page/5/Picture/1 description: The image shows a close-up of a textured surface with a pattern of horizontal lines and vertical connections. The lines appear to be slightly irregular, giving the surface a somewhat organic or hand-crafted look. The overall impression is one of a woven or grid-like structure, with the black lines contrasting against the white background.

| 510(k) Number (if known): | K983361 |
|---------------------------|-----------|
| Device Name: | PANAVIA F |

#### Indications For Use:

PANAVIA F is indicated for the following applications:

Cementation of metal crowns and bridges, inlays and onlays. 1)

Cementation of porcelain crowns, inlays and onlays. 2)

Cementation of to composite resin crowns, inlays and onlays 3)

Cementation of adhesion bridges and splints ক)

Cementation of metal cores and prefabrication posts 5)

Bonded amalgam restorations ର)

## ن منتدى

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96),

Susan Ruano

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number 198