BISCEM GI

K032597 · Bisco, Inc. · EMA · Nov 4, 2003 · Dental

Device Facts

• Record ID: K032597
• Device Name: BISCEM GI
• Applicant: Bisco, Inc.
• Product Code: EMA · Dental
• Decision Date: Nov 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2

Intended Use

BisCem GI is a dual-cure radiopaque dental cement designed to be used as a luting cement.

Device Story

BisCem GI is a dual-cured, resin-modified glass ionomer luting cement. It functions as a self-adhesive material, bonding to composite, metal, silanated porcelain, and tooth structure (dentin/enamel) without requiring separate adhesive or etching steps. The device is supplied in a dual-syringe system; clinicians mix paste A and paste B using a mixing tip for direct application to the working area. It can be self-cured or light-cured. Used by dental professionals in clinical settings to secure various dental restorations and appliances. The radiopaque properties assist in post-operative radiographic assessment.

Clinical Evidence

Bench testing only. Biocompatibility testing was performed to confirm the device is non-toxic. No clinical studies were required or provided.

Technological Characteristics

Dual-cured (light/self) resin-modified glass ionomer cement. Radiopaque. Dual-syringe delivery system with mixing tips. Low viscosity. Class II device per 21 CFR 872.3275.

Indications for Use

Indicated for luting metal crowns, bridges, inlays, and onlays (including porcelain-fused-to-metal and composite-to-metal); luting resin crowns, bridges, inlays, onlays, and veneers; luting metal or non-metal posts; luting orthodontic appliances; and luting porcelain inlays.

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

• GC FujiCem

Submission Summary (Full Text)

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510 (k) submission for BisCem GI BISCO INC., 1100 West Irving Park Road Schaumburg, IL 60193

# CONFIDENTIAL

K032597

Page 5-1

### Section 5

# NOV - 4 2003

## 510 (k) SUMMARY

This summary of 510 (k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 190 and 21 CFR par 807.92

Trade Name: BisCem GI

Common Name: Luting cement

Classification/Name: Material, Dental Cement Class II per 21 CFR 872.3275

#### Description of Application Device:

BisCem GI is a dual-cured resin modified glass ionomer cement. It is a self-adhesion cement bonding to composite, metal, silanated porcelain and tooth structure without applying any adhesive. For bonding to dentin and enamel, no etching step is required. With its dual syringe system, BisCem GI can be self cured by simply mixing paste A and paste B or cured by light after mixing paste A and paste B. Using a mixing tip, the cement could be dispensed to the working area directly.

#### Intended uses of Applicant Device:

BisCem GI is a dual-cure radiopaque dental cement designed to be used as a luting cement. Its physical properties are similar to the predicate device and uses are identical.

Predicate Device: GC FujiCem

| | BisCem GI | GC FUJICEM |
|-----------------------------------|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Intended use | Luting cement | Luting cement |
| Chemical composite | Dual-cured (light/self) dental<br>glass filled, resin modified glass<br>ionomer cement | Self-cured dental glass filled,<br>resin modified glass ionomer<br>cement |
| Mechanical/physical<br>properties | Low viscosity, dispensable<br>composite | Low viscosity, dispensable<br>composite |

#### Significant Performance Characteristics:

Side by side comparisons of BisCem GI to the predicate device GC FujiCem clearly demonstrates that the applicant device is substantially equivalent to the legally marked devices. BisCem GI was tested for biocompatibility and it was found to be non-toxic. It is concluded that the information supplied in this submission has proven the safety and efficacy of BisCem GI.

Kathy Joung, Ph.D. Director of Quality Systems Telephone: [phone] Fax: [phone]

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Image /page/1/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized caduceus with three lines representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the emblem in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 4 2003

Dr. Kathy Joung Director of Quality Systems Bisco. Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193

Re: K032597

Trade/Device Name: BisCem™ GI Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Codes: EMA, KLE, and DYH Dated: August 21, 2003 Received: August 29, 2003

Dear Dr. Joung:

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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## Page 2 – Kathy Joung, PhD

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,

Susan Punnis
for Chris S. Liem, 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

Enclosure

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510 (k) submission for BisCem Gl BISCO INC., 1100 West Irving Park Road Schaumburg, IL 60193

## CONFIDENTIAL

Page 2-2

510(k) Number (if known): <032597

Device Name: BisCem GI

Indications for Use:

- 1. Luting metal crowns, bridges, inlay, and onlays including porcelain-fused-tometal and composite-to-metal varieties;
- Luting resin crowns, bridges, inlays, onlays and veneers; 2.
- 3. Luting metal or non-metal posts;
- 4. Luting orthodontic appliances;
- 5. Luting porcelain inlays.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suer Purser

(Division Sign-General Hospital, Division of Anesthesion Infection Control,

510(k) Number

(Optional Format 3-10-98)