BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012

K082449 · Bisco, Inc. · EMA · Sep 25, 2008 · Dental

Device Facts

• Record ID: K082449
• Device Name: BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012
• Applicant: Bisco, Inc.
• Product Code: EMA · Dental
• Decision Date: Sep 25, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3275
• Device Class: Class 2

Intended Use

The modified formula is a dual-cure radiopague dental cement designed to be used as a luting cement. Its physical properties are similar to the predicate device and there has been no change in the intended use.

Device Story

BisCem is a dual-cured, self-etching, self-adhesive resin cement used for luting dental restorations. 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 with a mixing tip for direct dispensing to the working area. It can be self-cured or light-cured. Used by dental professionals in a clinical setting to secure crowns, bridges, inlays, onlays, veneers, posts, and orthodontic appliances. Refrigeration is required for storage; material must reach room temperature before use.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and performance characteristic comparisons.

Technological Characteristics

Dual-cured (self/light) dental glass-filled resin cement. Radiopaque. Dual-syringe delivery system with mixing tip. Self-etching and self-adhesive properties. Requires refrigeration.

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; 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 (K060701)

Submission Summary (Full Text)

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K052449

## Section 8 SPECIAL 510 (k) SUMMARY

SEP 2 5 2008

| Applicant: | Bisco, Inc.<br>1100 W. Irving Park Road<br>Schaumburg IL, 60193 |
|----------------------|------------------------------------------------------------------|
| Contact Person: | Michelle Schiltz-Taing<br>Tel: [phone]<br>Fax: [phone] |
| Date Prepared: | August 22, 2008 |
| 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 adhosive 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 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. Due to the unique chemistry of BisCem, refrigeration is necessary when not in use. Allow refrigerated BisCem to reach room temperature before use.

## Intended uses of Applicant Device:

The modified formula is a dual-cure radiopague dental cement designed to be used as a luting cement. Its physical properties are similar to the predicate device and there has been no change in the intended use.

Predicate Devices: BisCem cleared under (K060701) dated May 15, 2006.

| | BisCem | Modified |
|------------------------------------|----------------------------------------------------------------------------------------|--------------------------------------------------------------|
| 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<br>properties | Low viscosity, dispensable<br>composite | Low viscosity, dispensable<br>composite |

## Significant Performance Characteristics:

Side by side comparisons clearly demonstrate that the applicant device is substantially equivalem to the legally marketed device. It is concluded that the information supplied in this submission has proven the safety and efficacy of this product.

Page 8-1

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SEP 2 5 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Michelle Schiltz-Taing Regulatory Affairs Coordinator Bisco, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193

Re: K082449

Trade/Device Name: BISCEM Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: August 22, 2008 Received: September 5, 2008

Dear Ms. Schiltz-Taing:

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 - Ms. Schiltz-Taing

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I DA has made a determination that your device complics 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

TKhamult-Kendring
foel

Chiu S. Lin. Ph. D Division 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): K

BISCEM Device Name:

Indications for Use:

- 1. Luting metal crowns, bridges, inlay, and onlays including porcelain-fused-tometal and composite-to-metal varieties;
K082449

- 2. Luting resin crowns, bridges, inlays, onlays and veneers;
- 3. I 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 Runner

(Division Sign-Off) (Division of Anesthesiology, General Hospital infection Control, Dental Devices

510(k) Number: K082449