BISTITE II SC

K991711 · Tokuyama America, Inc. · EMA · Jul 7, 1999 · Dental

Device Facts

• Record ID: K991711
• Device Name: BISTITE II SC
• Applicant: Tokuyama America, Inc.
• Product Code: EMA · Dental
• Decision Date: Jul 7, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use as a dental cement in various applications, including luting, repair of fractured porcelains or crown and bridge resins, cementaiton of adhesive bridge prostheses and CR core posts.

Device Story

Bistite II SC is a self-curing dental cement used by dental practitioners for luting, repairing fractured porcelains or crown and bridge resins, and cementing adhesive bridges and CR core posts. The device is applied by the clinician to the dental site to facilitate bonding or repair. It is not intended for over-the-counter use. The product is supplied as a dental material that cures upon application. By providing a stable cementation medium, it assists in the structural restoration and fixation of dental prosthetics, benefiting patients by securing dental devices and repairing damaged restorations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Self-curing dental cement containing methacrylate monomers. Formulated for professional dental use. No specific ASTM standards or complex electronic/software components described.

Indications for Use

Indicated for dental practitioners for cementation of dental devices, luting, repair of fractured porcelains or crown and bridge resins, cementation of adhesive bridges, and CR core posts. Contraindicated for patients hypersensitive to methacrylate monomers.

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)
• Panavia Ex (K855211)
• C&B Metabond (K960464)

Submission Summary (Full Text)

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JUL -7 1999

# EXHIBIT D

### 510(k) Summary

Submitted by: Daniel J. Manelli Farkas & Manelli, P.L.L.C. 2000 M Street, NW (Suite 700) Washington, DC 20036

> On behalf of Tokuyama America, Inc. 510(k) Submission: Bistite II SC May 6, 1999

The product is a self curing dental cement for use in the cementation of dental devices, luting, repair of fractured porcelains or crown and bridge resins, cementation of adhesive bridges and CR core posts.

This product is for use only by dental practitioners; it is not intended for OTC use. It contains materials that pose no health hazard when used according to directions and has received the approval of the Japanese Government. It is substantially equivalent to various marketed dental cement products, including the following:

| Panavia 21 (Kurarey) | K933030 |
|------------------------|---------|
| Panavia Ex (Kurarey) | K855211 |
| C&B Metabond (Parkell) | K960464 |

The Use of the product is contra-indicated for patients who are hypersensitive to methacrylate monomers. It should not be allowed to come into contact with skin, eyes or clothing. Should contact with the eyes occur, the eyes should be thoroughly flushed with water followed by immediate contact to a physician.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 7 1999

Tokuyama America, Incorporated c/o Daniel J. Manelli Farkas & Manelli, P.L.L.C. 2000 M Street, N.W. 7th Floor Washington, DC 20036-3307

Re : K991711 Trade Name: Bistite II SC Regulatory Class: II Product Code: EMA May 17, 1999 Dated: May 19, 1999 Received:

### Dear Mr. Manelli:

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 general 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 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister.

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Page 2 - Mr. Manelli

this response to your premarket notification Please note: ricable note. Confor affect any obligation you might have under sections 531 through 542 of 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 fire roceer wire as 0 (k) premarket notification. The FDA deberroom in four in four alence of your device to a legally marketed predicate device results in a classification for your marice 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 compriation 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" (21 CFR 807.97). Other general 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

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

Enclosure

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Page 1 of 1

510(k) Number (if known):_| < 9 9 \ 7 \

Tokuyama Bistite II SC Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

ಿ ಸಾಮಾನ್ಯ ಸಂಪ

కార్డులున్నారు. గ్రామం

For use as a dental cement in various applications, including luting, repair of fractured porcelains or crown and bridge resins, cementaiton of adhesive bridge prostheses and CR core posts.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Susan Ruise

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