METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING

K032605 · Meta Biomed Co., Ltd. · KIF · Oct 8, 2003 · Dental

Device Facts

• Record ID: K032605
• Device Name: METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING
• Applicant: Meta Biomed Co., Ltd.
• Product Code: KIF · Dental
• Decision Date: Oct 8, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

Metapaste is a biocompatible root canal sealer used for the temporary filling of root canals after endodontic surgery. Metapaste can be used on its own and for vital pulpdectomies in decidious teeth. Metapaste is intended for use by qualified healthcare personnel trained in its use.

Device Story

Metapaste is a premixed calcium hydroxide and barium sulfate paste used as a temporary root canal sealer. The device is supplied in a plastic syringe with disposable applicator tips and a plastic ring rotator for tip direction control. It is intended for use by qualified dental professionals in a clinical setting. The paste is dispensed directly into the root canal. It functions as a biocompatible filling material to protect the pulp and seal the canal. The device is ready-to-use, simplifying the clinical workflow for endodontic procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including ISO 6876 standards (fluidity, working time, film thickness, radiopacity, solubility, and disintegration) and biocompatibility testing (ISO/TR 7405 Agar diffusion test and ISO 10993-11 acute intravenous application).

Technological Characteristics

Calcium hydroxide and barium sulfate paste. Premixed, ready-to-use. Packaged in plastic syringe with disposable applicator tips. Complies with ISO 6876 (dental root canal sealing materials). Biocompatibility per ISO 10993-11 and ISO/TR 7405. No electronic components or software.

Indications for Use

Indicated for temporary root canal filling after endodontic surgery and for vital pulpdectomies in deciduous teeth. Intended for use by trained healthcare personnel.

Regulatory Classification

Identification

A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.

Predicate Devices

• Pulpdent Calcium Hydroxide Preparation (K022734)
• Pulpdent Calcium Hydroxide Preparations (Tempcanal) (K944945)

Submission Summary (Full Text)

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K032605

OCT - 8 2003

| 1 | 510(k) Summary | |
|-----|------------------------------|---------------------------------------------------------------------------------------------------------------------|
| 1.1 | Date of Summary Preparation: | June 26, 2003 |
| 1.2 | Submitter/Contact Person: | Jenny Sohn, Official Correspondent |
| | | TEL [phone]<br>FAX [phone]<br>Meta Dental Co.<br>41-19, 77 ^th Street<br>Elmhurst, NY 11373 |
| 1.3 | Trade Name/Common Name: | Metapaste Calcium Hydroxide with Barium<br>Sulfate Temporary Root Canal Filling |
| 1.4 | Common Name: | Temporary Root Canal Sealer |

#### Classification Name, Product Code, Class, Classification Reference: 1.5

| Classification Name | Product Code | Class | 21CFR § |
|--------------------------|--------------|-------|----------|
| Root Canal Filling Resin | KIF | II | 872.3820 |

#### Standards/Special Controls: 1.6

ISO 6876 Dental root canal sealing materials.

#### Indications for Use: 1.7

Metapaste is a biocompatible root canal sealer used for the temporary filling of root canals after endodontic surgery. Metapaste can be used on its own and for vital pulpdectomies in decidious teeth.

Metapaste is intended for use by qualified healthcare personnel trained in its use.

#### 1.8 Device Description:

Metapaste calcium hydroxide with Barium Sulfate is a device consisting of a temporary root canal sealer paste contained within a plastic syringe, packaged with disposable applicator tips and a plastic ring rotator for direction control of the tip. It is a device intended for use by qualified healthcare personnel trained in its use.

The Metapaste device is similar in design, materials and intended use to other 510(k) cleared devices which are in commercial distribution.

#### Substantially Equivalent Commercially Available Devices: 1.9

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The Metapaste device is substantially equivalent to the predicate device described hercin with respect to indications for use, device design, materials, and method of manufacture:

Pulpdent Calcium Hydroxide Preparation - K022734

Pulpdent Calcium Hydroxide Preparations -- K944945 (Device Listing: Tempcanal-Temporary Calcium Hydroxide Root Canal Treatment 21 CFR § 872.3250)

The predicate devices are commercially available and a marketed Class II device indicated for use as a temporary root canal sealer.

#### 1.10 Substantial Equivalence Comparison:

Metapaste is similar to commercially available device with respect to intended use, material, design and operational principles as follows:

| | Metapaste | Pulpdent Calcium | Pulpdent Calcium |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Hydroxide Preparation | Hydroxide Preparation |
| | | (Tempcanal K944945) | (K022734) |
| Labelling | Temporary root canal<br>sealer | Temporary root canal sealer | Temporary or permanent root<br>canal sealer |
| Intended Use | Metapaste is a<br>biocompatible root<br>canal sealer used for the<br>temporary filling of<br>root canals after<br>endodontic surgery.<br>Metapaste can be used<br>on its own and for vital<br>pulpdectomics in<br>decidious teeth.<br>Metapaste is intended<br>for use by qualified<br>healthcare personnel<br>trained in its use. | A calcium hydroxide cavity<br>liner material intended to be<br>applied to the interior of a<br>prepared cavity before<br>insertion of restorative<br>material, such as amalgam, 10<br>protect the pulp of a tooth. | A biocompatible<br>polydimethylsiloxane based<br>root canal sealer used for the<br>temporary and permanent<br>filling of root canals after<br>endodontic surgery. Can be<br>used on its own, in<br>conjunction with Gutta Percha<br>and for vital pulpdectomies in<br>deciduous tecth. |
| Human<br>Factors | Dispensed ready to use | Dispensed ready to use | Dispensed ready to use |
| Similar | ISO 6876 Fluidity. | ISO 6876 Fluidity, Working | ISO 6876 Fluidity, Working |
| Physical | Working Time, Film | Time, Film Thickness, | Time, Film Thickness, |
| Properties | Thickness, Radiopacity,<br>Solubility & | Radiopacity, Solubility &<br>disintegration | Radiopacity, Solubility &<br>disintegration |
| | disintegration | | |
| Biocompatibil<br>ity | Freedom from toxicity<br>per ISO/TR 7405 Agar<br>diffusion test | Freedom from toxicity per<br>ISO/TR 7405 Agar diffusion<br>ાટડા | Biocompatible |
| | Biocompatible per ISO<br>10993-11 Acute<br>intervenous application | Biocompatible per ISO 10993-<br>11 Acute intervenous<br>application | |

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| | Metapaste | Pulpdent Calcium<br>Hydroxide Preparation<br>(Tempcanal K944945) | Pulpdent Calcium<br>Hydroxide Preparation<br>(K022734) |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Design,<br>Construction,<br>Components | Premixed paste,<br>packaged in plastic<br>syringe ready to be<br>dispensed through<br>disposable tips into root<br>canal | Premixed paste, packaged in<br>plastic syringe ready to be<br>dispensed through disposable<br>tips into root canal | Premixed paste, packaged in<br>plastic syringe ready to be<br>dispensed through disposable<br>tips into root canal |

#### 1.11 Indications and Contraindications:

Relative indications and contraindications for Metapaste and commercially available devices for similar intended uses are the same.

#### 1.12 Conclusion:

In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this pre-market notification, Meta Biomed Co., Ltd concludes that the new device, Metapaste root canal sealer, is safe, effective and substantially equivalent to the predicate device as described herein.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 8 2003

Meta Biomed Company Limited Institute C/O Mr. Ned Devine Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548

Re: K032605

Trade/Device Name: Metapaste Calcium Hydroxide with Barium Sulfate Root Canal Filling Regulation Number: 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: September 22, 2003 Received: September 23, 2003

Dear Mr. Devine:

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. Devine

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 (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 vou 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" (21CFR 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/dsma/dsmamain.html

Sincerely yours,

Clues

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# K 032605

## Indications for Use

Page 1_of_1

## 510(k) Number:

Device Name : Metapaste Calcium Hydroxide with Barium Sulfate Root Canal Filling

### Indications for Use:

For use, as a temporary root canal filling after endodontic surgery. Metapaste can be used on its own and for vital pulpdectomies in decidious teeth.

Metapaste is intended for use by qualified healthcare personnel trained in its use.

Susan Runno

510(k) Number:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use