This product is a device composed of materials such as dimethaclylate monomers intended to affix dental devices such as crowns or bridges. It is classified into Dental cement other than zinc oxide-eugenol, CFR 29 Section 872.3275.

AI/ML Overview

This submission describes a 510(k) premarket notification for a change in manufacturer name and address for an existing device, PANAVIA 21. As such, the submission does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The manufacturer explicitly states, "The aim of 510(k) submission is to alter the name and address of manufacturer, and not to intend other changes," and "This device is essentially the same as PANAVIA 21 manufactured by Kuraray Co., Ltd. (K933030). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as PANAVIA 21."

Therefore, the requested details regarding acceptance criteria and studies are not available in the provided document.

Summary

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

SEP - 5 2001

[PANAVIA 21, Kuraray Medical Inc.]

Image /page/0/Picture/2 description: The image shows a sequence of alphanumeric characters. The sequence starts with the letter 'K', followed by the letter 'O', then the number '1', the number '2', the number '4', the number '3', and ends with the number '8'. The characters are written in a bold, sans-serif font.

Image /page/0/Picture/3 description: The image is a logo for Kuraray. The logo is a black square with a white "K" and "G" inside. The word "KURARAY" is written in white letters below the square. The logo is simple and modern.

39, 1-Chome, Umeda, Kita-ku, Osaka 530-8611, JAPAN e- +81-6-348-2552

RARAY MEDICAL INC.

510(k) SUMMARY

1. Submitter

Name
Date
Address

KURARAY MEDICAL INC. 1621 Sakazu, Kurashiki, Okayama 710-8622, Japan Koji Nishida 3) Contact person DENTAL MATERIAL DEPARTMENT July 23, 2001 Masaya Sasaki 5) Contact person in U.S.A. 30th Fl. Metlife Building, 200 Park Avenue, New York,

Facsimile : (212)-867-3543

1(800)-879-1676

Telephone : (212)-986-2230

Name of Device

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

NY 10166

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.

PANAVIA 21 by Kuraray Co., Ltd. 1.

(K933030)

Description for the premarket notification

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

Statement of the intended use

The intended uses of this device are as follows. They are completely the same as PANAVIA 21 manufactured by Kuraray Co., Ltd. (K933030).

Cementation of adhesion bridges or splints 1)
Cementation of metal crowns, bridges and inlays/onlays 2)
Cementation of silanated porcelain and cured composite crowns or inlays/onlays 3)
Cementation of preformed posts or cast post and cores 4)
1. Bonded amalgam restoratios
1. Statement of the technological characteristics and safety

This device is essentially the same as PANAVIA 21 manufactured by Kuraray Co., td. (K933030). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as PANAVIA 21.

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

Image /page/2/Picture/1 description: The image contains a cropped portion of text. The text says "T OF HEALTH &" in a bold, sans-serif font. The text is black against a white background.

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol featuring a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

SEP = 5 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 : K012438 Modification To Panavia 21 Trade/Device Name: 872.3275 Regulation Number: Requlatory Class: II Product Code: EMA July 23, 2001 Dated: Received: July 31, 2001

Dear Ms. Sasaki:

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 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action.

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

Page 2 - Ms. Sasaki

concerning your device in the Federal Register. Please note: this response to your premarket notification submission does chis response to your pro you might have under sections 531 not arreet any obsignt for devices under the Electronic cirough 542 OF the not of other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your alence of your device to a legally marketed predicate device results in a classification for your marketed predicate actre 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 regaracter ( Compliance at (301) 594-4613. Additionally, for questions on compramotion 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, Obtained From Cho 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 Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

[PANAVIA 21, Kuraray Medical Inc.]
K012438

510(k) Number (if known): K012438

Device Name: PANAVIA 21

Indications for Use

PANAVIA 21 is indicated for the following applications:

Cementation of adhesion bridges or splints
Cementation of metal crowns, bridges and inlays/onlays
Cementation of silanated porcelain and cured composite crowns or inlays/onlays
Cementation of preformed posts or cast post and cores
Bonded amalgam restoratios

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use_

(Optional Format 1-2-96)

Susan Runge

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

Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)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.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. 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.(2)
Classification. Class II.