BISTITE II DC

K011685 · Tokuyama America, Inc. · EMA · Jul 31, 2001 · Dental

Device Facts

• Record ID: K011685
• Device Name: BISTITE II DC
• Applicant: Tokuyama America, Inc.
• Product Code: EMA · Dental
• Decision Date: Jul 31, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2

Intended Use

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

Device Story

Bistite II DC is a dental cement capable of light-curing or self-curing. Used by dental practitioners for luting, repairing fractured bridge resins, and cementing adhesive bridge prostheses and CR core posts. Applied by clinicians in a dental office setting. The device functions as a restorative material to secure dental prosthetics and posts. Benefits include clinical utility in various restorative dental procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Dental cement containing methacrylate monomers. Dual-cure system (light-cure or self-cure). Class II medical device (Product Code: EMA).

Indications for Use

Indicated for use as a dental cement for luting, repair of fractured bridge resins, cementation of adhesive bridge prostheses, 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

• Bistite II SC (Tokuyama) (K991711)
• Panavia 21 (Kurarey) (K933030)
• C&B Metabond (Parkhill) (K960464)

Submission Summary (Full Text)

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JUL 3 1 2001

KO11685

Exhibit D

## 510(k) Summary

Submitted by:

Daniel J. Manelli Manelli Denison & Selter, P.L.L.C. 2000 M Street, NW (Suite 700) Washington, DC 20036

Telephone: [phone]

On behalf of Tokuyama America, Inc. 510(k) Submission: Bistite II DC May 30, 2001

The product is a dental cement which can be either light cured or self cured. It is
it is a The product is a dental center. Which ban be of carries, luting, repair of fractured intended for use in the cententation of achial as a man as a many of adhesive bridges and CR core posts.

The product is for use only by dental practitioners; it is not intended for OTC use.
The product is for use only be has weed according to directions The product is for use only by dontal practice/
It contains materials that pose no health hazard when used according to directions It contains materials that poss no health miles. It is substantially and has received the approval of the ouplines including the following:
equivalent to various marketed dental cement products, including the following:

| Bistite II SC (Tokuyama) | K991711 |
|--------------------------|---------|
| Panavia 21 (Kurarey) | K933030 |
| C&B Metabond (Parkhill) | K960464 |

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 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 often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 31 2001

Tokuyama America, Incorporated C/O Mr. Daniel J. Manelli Attorney Manelli, Denison & Selter, P.L.L.C. riano M Street, NW Suite 700 Washington, D.C. 20036

K011685 Re : Bistite II DC Trade/Device Name: Regulation Number: 872.3275 II Requlatory Class: Product Code: EMA Dated: May 30, 2001 Received: May 31, 2001

Dear Mr. Manelli:

We have reviewed your Section 510(k) notification of intent to
r the back of the freenced showe and we have determined the We have reviewed your seccion from and we have determined the
market the device referenced above and indications for market the device referenced above and a a sudications for
device is substantially equivale maketed predicate device is substancially equilible and the enclosed predicate use stated in the enclosure, co regard market prior to May 28, 2976,
devices marketed in interstate commerce proior to to devices marketed in Interstate commons. Famendments, or to
the enactment date of the Medical in agardance with the the enactment date of the medical bon accordance with the devices that have been recraborrag, and Cosmetic Act (Act).
provisions of the Federal Food, Irvice, subject to the general provisions of the Federal rood, bray, and sect to the general You may, therefore, marries act. The general controls controls provisions of the Act include requirements for annual provisions of the Act Include required manufacturing practice,
registration, listing of devices, good manufacturing and registration, firsting or as as as as a respeared ing and adulteration.

If your device is classified (see above) into either class II
n the may of a classified (seessar Approval), it may If your device Is class III (Passarket Approval), it may
(Special Controls) or class III (Premarket - Exicting major (Special Controls) of Crabb I controls. Existing major be subject to such addicionar controlly. Efound in the Code of Fegulations arrecting your til, Parts 800 to 895.
Federal Regulations, Title 21, Partison accument com ਸ Federal Regulations, firtle 21, facts oversion assumes compliance with substantially equivalence decembered requirements, as set
the Current Good Manufacturing Practice requirements, as set the Current Good Manafacturing - alation (QS) for Medical
forth in the Quality System Regulation (QS) and that forth In the Quarter ByBoom 12) CFR Part 820) and that, Devices: General regarations, the Food and Drug
through periodic QS inspections, the sugh acqumptions through periodic QS inspections, such assumptions. Failure to
Administration (FDA) will verify such assumptions. Failure to Administration (FDA) will version may result in regulatory comply with the GMP regulation may publish further announcements
action. In addition, FDA the Federal Register Please not action. In addition, FBA may publish leaderal Register. Please note:

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Page 2 - Mr. Manelli

this response to your premarket notification submission does this response to your premaince necessve under sections 531
not affect any obligation you might have under the Flectronic not affect any obligation you might under the Electronic through 542 of the Act IOF devices and on other Federal laws or requlations.

This letter will allow you to begin marketing your device as This letter will allow you conney motification. The FDA described in your 510(x) premarke norrroadevice to a legally
finding of substantial equivalence of your device for vour finding of substantial equivation of yourseification for your marketed predicate device resures in a orabbeared.
device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling If you desire specific acvice tor goal and additionally 809.10 for in
regulation (21 CFR Part 801 and additionally Office of regulation (21 CFR Farc bor anase contact the Office of vitro diagnostic devices), predbe otionally, for questions on
Compliance at [phone]. Additionally, plaase contact Compliance at [phone]. Addressederice, please contact
the promotion and advertising of your device, please no the promotion and advertising of your association of the Office of Compliation of Compliation the orrios on entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general premarket notification (zich over the Act may be information on your responsibliation and Manufacturers Assistance
obtained from the Division of Small Manufacturers [phone] or obtained from the DIVISION OF Bilair Handadoomaal
at its toll-free number [phone] or [phone] or at its internet address

it3 Internet addrebb
"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy/ Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Exhibit C

Page __ 1__ of __ 1__ 1__

510(k) Number (if known): K011685

Tokuyama Bistite II DC_ Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

For use as a dental cement in various applications, including luting, repair of
es as a dental comed bridge resins, cemtation of adhesive bridge For use as a dental cement in vanous applioutions, moraling and besive 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)

OR

Susan Runn

(Division Sign-Off) (Division Sign-Off)
Division of Dental, Infection Control,
Division of Dental, Infection Devices Division of Dentshital Device 510(k) Number -

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use_