THERACAL LC

K063237 · Bisco, Inc. · EJK · Dec 8, 2006 · Dental

Device Facts

• Record ID: K063237
• Device Name: THERACAL LC
• Applicant: Bisco, Inc.
• Product Code: EJK · Dental
• Decision Date: Dec 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TheraCal LC is a light-cure resin-based, mineral trioxide aggregate (MTA) filled, liner designed Theracal De is a liner and pulp capping material.

Device Story

TheraCal LC is a light-cured, resin-based, mineral trioxide aggregate (MTA) filled dental material. It functions as a protective barrier and pulp capping agent for the dental pulpal complex in deep cavity preparations. The device is applied by a dental practitioner; it is dispensed as a low-viscosity composite and cured using a visible light curing unit. The hydrophilic resin formulation allows for a command set, enabling immediate placement and condensation of subsequent restorative materials. By providing a stable, durable liner, it protects the pulp and facilitates clinical restorative procedures.

Clinical Evidence

Bench testing only. Biocompatibility testing was performed, confirming the device is non-toxic. No clinical trial data was provided.

Technological Characteristics

Light-cured, resin-based liner filled with mineral trioxide aggregate (MTA). Low-viscosity, dispensable composite form factor. Cured via visible light curing unit. Class II device per 21 CFR 872.3250.

Indications for Use

Indicated for use as a dental liner and pulp capping agent in deep cavity preparations.

Regulatory Classification

Identification

A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.

Predicate Devices

• Prisma VLC Dycal (K922721)

Submission Summary (Full Text)

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K 063237

Page 5-1

# Section 5 510 (k) SUMMARY

| Applicant: | Bisco, Inc. |
|----------------------|----------------------------------|
| | 1100 W. Irving Park Road |
| | Schaumburg IL, 60193 |
| Contact Person: | Benjamin Lichtenwalner |
| | Tel: [phone] |
| | Fax: [phone] |
| Date Prepared: | October 25, 2006 |
| Trade Name: | TheraCal LC |
| Common Name: | Liner & Pulp Capping Material |
| Classification/Name: | Liner, Cavity, Calcium Hydroxide |
| | Class II per 21 CFR 872.3250 |

DEC - 8 2006### Description of Applicant Device:

TheraCal LC is a light-cured resin-based, mineral trioxide aggregate (MTA) filled, liner designed to perform as a barrier and to protect the dental pulpal complex. TheraCal LC's precise alacement allows its use in all deep cavity preparations. The light-cured set permits the practitioner immediate placement and condensation of the restorative material. Its proprietary practitioner intines for a command set with a visible light curing unit while maintaining ease of formulation anows for a ochimaners and one oprietary hydrophilic resin formulation creates a stable and durable liner or base

### Intended uses of Applicant Device:

TheraCal LC is a light-cure resin-based, mineral trioxide aggregate (MTA) filled, liner designed Theracal De is a liner and pulp capping material. Its physical properties and uses are similar to the predicate device.

Predicate Devices: Prisma VLC Dycal cleared under (K922721) dated July 23, 1992.

| | Prisma VLC Dycal | TheraCal LC |
|------------------------------------|-------------------------------------------------------|-------------------------------------------------------------------------|
| Intended use | Liner & Pulp Capping Material | Liner & Pulp Capping Material |
| Chemical composite | Light-cured, Calcium Hydroxide<br>filled, resin liner | Light-cured, MTA (Mineral<br>Trioxide Aggregate) filled, resin<br>liner |
| Mechanical /physical<br>properties | Low viscosity, dispensable<br>composite | Low viscosity, dispensable<br>composite |

# Significant Performance Characteristics:

Side by side comparisons of TheraCal LC to the predicate device Prisma VLC Dycal clearly demonstrates that the applicant device is substantially equivalent to the legally marked device. TheraCal LC 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 TheraCal LC.

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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 with three lines representing its wings and a wavy line representing its body. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

DEC - 8 2006

Re: K063237

Trade/Device Name: TheraCal LC Regulation Number: 21 CFR 872.3250 Regulation Name: Calcium Hydroxide Cavity Liner Regulatory Class: II Product Code: EJK Dated: October 25, 2006 Received: October 26, 2006

Dear Mr. Lichtenwalner:

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 - Mr. Benjamin Lichtenwalner

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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Sujata Y. Michlen DMD.

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

and we will be and the country of the count

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16663757 510 (k) Number (if known):

TheraCal LC Device Name:

Indications for Use:

- 1. Liner
- 2. Pulp capping agent

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

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 Rumor

(Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

0632337