BISCEM TRANSLUCENT, BISCEM OPAQUE

K060701 · Bisco, Inc. · EMA · May 15, 2006 · Dental

Device Facts

• Record ID: K060701
• Device Name: BISCEM TRANSLUCENT, BISCEM OPAQUE
• Applicant: Bisco, Inc.
• Product Code: EMA · Dental
• Decision Date: May 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

BisCem is a dual-cured, self-etching, self-adhesive resin luting cement. It bonds to composite, metal, silanated porcelain, and tooth structure 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 dispensing to the working area. It can be self-cured or light-cured. Used by dental professionals in clinical settings to secure dental restorations (crowns, bridges, inlays, onlays, veneers, posts, and orthodontic appliances). The cement provides radiopacity and physical properties similar to existing resin-modified glass ionomer cements, facilitating stable restoration placement.

Clinical Evidence

Bench testing only. Biocompatibility testing was performed, confirming the device is non-toxic.

Technological Characteristics

Dual-cured (self/light) resin cement; radiopaque; low-viscosity; dispensable composite; dual-syringe delivery system with mixing tip.

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/fiber posts; and luting orthodontic appliances; and luting porcelain inlays, onlays, crowns, and veneers (including alumina and zirconia).

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

• BisCem GI (K032597)

Submission Summary (Full Text)

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060701

## Section 5 510 (k) SUMMARY

"" + 5 more

| Applicant: | Bisco, Inc.<br>1100 W. Irving Park Road<br>Schaumburg IL, 60193 |
|----------------------|------------------------------------------------------------------|
| Contact Person: | Benjamin Lichtenwalner<br>Tel: [phone]<br>Fax: [phone] |
| Date Prepared: | March 15, 2006 |
| Trade Name: | BisCem |
| Common Name: | Luting Cement |
| Classification/Name: | Material, Dental Cement<br>Class II per 21 CFR 872.3275 |

#### Description of Applicant Device:

BisCem is a dual-cured self etching and self adhesive resin cement. It is a self-adhesive cement since it bonds to composite, metal, silanated porcelain and tooth structure without applying any adhesive. No etching step is required to bond to dentin or enamel. With its dual syringe system, BisCem 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. It is intended for use as a luting cement.

### Intended uses of Applicant Device:

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

Predicate Devices: BisCem GI cleared under (K032597) dated November 4, 2003.

#### Significant Performance Characteristics:

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

Side by side comparisons of BisCem to the predicate device BisCem GI clearly demonstrates that the applicant device is substantially equivalent to the legally marked device. BisCem 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.

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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 and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.

### Public Health Ser

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 15 2006

Mr. Benjamin Lichtenwalner Regulatory Affairs Coordinator Bisco, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193

Re: K060701

Trade/Device Name: BisCem Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: May 02, 2006 Received: May 05, 2006

Dear Mr. Lichtenwalner:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave levicwed your Section of the device is substantially equivalent (for the indications for releteed above and have decommised are of cated predicate devices marketed in interstate commerce use stated in the encreasure) to regain than of the Medical Device Amendments, or to devices that provision in the provisions in the provisions of the Federal Food, Drug, Drug, and Cosmetic liave been roomsonied in are approval of a premarket approval application (PMA). You may, Act (Act) market the device, subject to the general controls provisions of the Act. The general therefore, market the do need, basyev remirements for annual registration, listing of devices, good controls provide or assess on prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be may or subject to subli additions, 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 - Mr. Benjamin Lichtenwalner

Please he 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 (OS) 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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Sylette Y. Michine Om-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) Number (if known):

BISCEM Device Name:

Indications for Use:

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

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runo

Sizm-Chi) in of Anesthesiology, General Hospital, tion Control, Dental Devices

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