METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING

K032603 · Meta Biomed Co., Ltd. · KIF · Oct 7, 2003 · Dental

Device Facts

• Record ID: K032603
• Device Name: METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING
• Applicant: Meta Biomed Co., Ltd.
• Product Code: KIF · Dental
• Decision Date: Oct 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

Metapex calcium hydroxide with lodoform is a biocompatible temporary or permanent root canal sealer, for use to stimulate healing process due to the mixture of calcium hydroxide and iodoform and the induction effect of these two ingredients. Used to promote healing effects and to help prevent bacterial contamination of the canal, as the two ingredients improve the induction effect for hard tissue induction and deposition. To be used as a medicament for the treatment of infected root canals, and as a permanent, low volume additive to the filling process of a treated root canal to assist in the induction and deposition of hard tissue to make the healing process more rapid and complete. For use in the treatment of infected root canals, or following pulpectomy, or for apexegenesis or apexificaation, and/or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha. Metapex is intended for use by qualified healthcare personnel trained in its use.

Device Story

Metapex is a premixed calcium hydroxide and iodoform paste used as a root canal sealer. It is supplied in a plastic syringe with disposable applicator tips and a ring rotator for tip direction control. The device is used by dental professionals in a clinical setting to promote healing, prevent bacterial contamination, and assist in hard tissue induction within the root canal. The paste is dispensed directly into the prepared canal. It functions as a medicament and a filling additive to facilitate rapid and complete healing. The device is intended for prescription use only.

Clinical Evidence

Bench testing only. The device was evaluated for physical properties per ISO 6876 (fluidity, working time, film thickness, radiopacity, solubility, and disintegration) and biocompatibility per ISO/TR 7405 (agar diffusion test) and ISO 10993-11 (acute intravenous application). No clinical data was provided.

Technological Characteristics

Premixed calcium hydroxide and iodoform paste. Packaged in a plastic syringe with disposable applicator tips and a plastic ring rotator. Complies with ISO 6876 (dental root canal sealing materials) and ISO 10993-11 (biocompatibility).

Indications for Use

Indicated for use in patients requiring root canal therapy, including treatment of infected root canals, post-pulpectomy, apexogenesis, apexification, or as a tip filling during final gutta-percha obturation. 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

• Vitapex Pre-Loaded Dental Syringe (K973667)

Submission Summary (Full Text)

{0}------------------------------------------------

#### OCT = 7 2003 510(k) Summary 1

- Date of Summary Preparation: July 30, 2003 1.1
Jenny Sohn, Official Correspondent 1.2 Manufacturers Contact Person: TEL [phone] FAX [phone] Meta Dental Co. 41-19, 77th Street

Elmhurst, NY 11373

#### 1.3 Metapex Trade Name:

#### Classification Name, Product Code, Class, Classification Reference: 1.4

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

## 1.5 Standards/Special Controls:

ISO 6876 Dental root canal sealing materials.

#### 1.6 Indications for Use:

Metapex calcium hydroxide with lodoform is a biocompatible temporary or permanent root canal sealer, for use to stimulate healing process due to the mixture of calcium hydroxide and iodoform and the induction effect of these two ingredients. Used to promote healing effects and to help prevent bacterial contamination of the canal, as the two ingredients improve the induction effect for hard tissue induction and deposition. To be used as a medicament for the treatment of infected root canals, and as a permanent, low volume additive to the filling process of a treated root canal to assist in the induction and deposition of hard tissue to make the healing process more rapid and complete. For use in the treatment of infected root canals, or following pulpectomy, or for apexegenesis or apexificaation, and/or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha.

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

#### 1.7 Device Description:

Metapex calcium hydroxide with lodoform 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 Metapex device is similar in design, materials and intended use to other 510(k) cleared devices which are in commercial distribution.

{1}------------------------------------------------

### Substantially Equivalent Commercially Available Devices: 1.8

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

Vitapex Pre-Loaded Dental Syringe ~ (K973667)

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

#### 1.9 Substantial Equivalence Comparison:

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

| | Metapex | Vitapex Pre-Loaded Dental<br>Syringe |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Labelling | Temporary or permanent root<br>canal sealer | Temporary or permanent root<br>canal sealer |
| Intended Use | For use, as a temporary or<br>permanent root canal sealer, to<br>stimulate healing process due to<br>the mixture of calcium hydroxide<br>and iodoform and the induction<br>effect of these two ingredients.<br>Used to promote healing effects<br>and to help prevent bacterial<br>contamination of the canal, as the<br>two ingredients improve the<br>induction effect for hard tissue<br>induction and deposition. To be<br>used as a medicament for the<br>treatment of infected root canals,<br>and as a permanent, low volume<br>additive to the filling process of a<br>treated root canal to assist in the<br>induction and deposition of hard<br>tissue to make the healing process<br>more rapid and complete. For use<br>in the treatment of infected root<br>canals, or following pulpectomy, or<br>for apexegenesis or apexificaation,<br>and/or for the tip filling of prepared,<br>treated root canals at the time of<br>final filling with gutta-percha.<br>Intended for use by qualified<br>healthcare personnel trained in its<br>use. | For use, as a temporary or<br>permanent root canal sealer, to<br>stimulate healing process due to<br>the mixture of calcium hydroxide<br>and iodoform and the induction<br>effect of these two ingredients.<br>Used to promote healing effects<br>and to help prevent bacterial<br>contamination of the canal, as the<br>two ingredients improve the<br>induction effect for hard tissue<br>induction and deposition. To be<br>used as a medicament for the<br>treatment of infected root canals,<br>and as a permanent, low volume<br>additive to the filling process of a<br>treated root canal to assist in the<br>induction and deposition of hard<br>tissue to make the healing<br>process more rapid and complete.<br>For use in the treatment of<br>infected root canals, or following<br>puipectomy, or for apexegenesis<br>or apexificaation, and/or for the<br>tip filling of prepared, treated root<br>canals at the time of final filling<br>with gutta-percha.<br>Intended for use by qualified<br>healthcare personnel trained in its<br>use. |
| Human<br>Factors | Dispensed ready to use | Dispensed ready to use |
| Similar<br>Physical<br>Properties | ISO 6876 Fluidity, Working Time,<br>Film Thickness, Radiopacity,<br>Solubility & disintegration | ISO 6876 Fluidity, Working Time,<br>Film Thickness, Radiopacity,<br>Solubility & disintegration |

{2}------------------------------------------------

| | Metapex | Vitapex Pre-Loaded Dental<br>Syringe |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | Freedom from toxicity per ISO/TR<br>7405 Agar diffusion test | Freedom from toxicity per ISO/TR<br>7405 Agar diffusion test |
| | Biocompatible per ISO 10993-11<br>Acute intervenous application | Biocompatible per ISO 10993-11<br>Acute intervenous application |
| Design,<br>Construction,<br>Components | Premixed paste, packaged in<br>plastic syringe ready to be<br>dispensed through disposable tips<br>into root canal | Premixed paste, packaged in<br>plastic syringe ready to be<br>dispensed through disposable tips<br>into root canal |

### 1.10 Indications and Contraindications:

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

#### 1.11 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, Metapex root canal sealer, is safe, effective and substantially equivalent to the predicate device as described herein.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 7 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: K032603

Trade/Device Name: Metapex Calcium Hydroxide with Lodoform 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.

{4}------------------------------------------------

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 (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 vour 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" (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, >

Quls

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

Enclosure

{5}------------------------------------------------

032603

# Indications for Use

Page 1 of

1

510(k) Number:

Metapex Calcium Hydroxide with lodoform Root Canal Filling Device Name :

## Indications for Use:

Metapex calcium hydroxide with lodoform is a biocompatible temporary or permanent root canal sealer, for use to stimulate healing process due to the mixture of calcium hydroxide and iodoform and the induction effect of these two ingredients. Used to promote healing effects and to help prevent bacterial contamination of the canal, as the two ingredients improve the induction effect for hard tissue induction and deposition. To be used as a medicament for the treatment of infected root canals, and as a permanent, low volume additive to the filling process of a treated root canal to assist in the induction and deposition of hard tissue to make the healing process more rapid and complete. For use in the treatment of infected root canals, or following pulpectorny, or for apexedenesis or apexificaation, and/or for the tip filling of prepared, treated root canals at the time of final filling with qutta-percha.

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

Suer Rump

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

510(k) Number:

(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