K Number
K032603
Device Name
METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING
Date Cleared
2003-10-07

(43 days)

Product Code
Regulation Number
872.3820
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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.
More Information

Not Found

No
The device description and intended use focus on the chemical properties and physical delivery of a root canal sealer paste, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".

Yes
The device is described as stimulating the healing process, promoting healing effects, and assisting in hard tissue induction and deposition, which are all therapeutic actions aimed at treating a medical condition (infected root canals) and restoring health.

No

Explanation: The "Intended Use / Indications for Use" section describes Metapex as a "temporary or permanent root canal sealer" and a "medicament for the treatment of infected root canals." Its purpose is to facilitate healing and prevent bacterial contamination, not to diagnose a condition or disease.

No

The device description explicitly states it is a paste contained within a plastic syringe, packaged with disposable applicator tips and a plastic ring rotator, indicating it is a physical medical device, not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use describes the device as a "temporary or permanent root canal sealer" and a "medicament for the treatment of infected root canals." It is used in vivo (within the body) to stimulate healing and prevent bacterial contamination within the root canal.
  • Device Description: The device is a paste delivered via a syringe for direct application into the root canal.
  • Lack of In Vitro Activity: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease.

IVD devices are used to perform tests on samples like blood, urine, or tissue to diagnose or monitor medical conditions. This device is used directly within the patient's body for therapeutic purposes.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

KIF

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

root canals

Indicated Patient Age Range

Not Found

Intended User / Care Setting

qualified healthcare personnel trained in its use.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K973667

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 872.3820 Root canal filling resin.

(a)
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.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

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 (718)-639-7460 FAX (718)-639-7408 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 NameProduct CodeClass21CFR §
Root Canal Filling ResinKIFII872.3820

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
Syringe |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Labelling | Temporary or permanent root
canal sealer | Temporary or permanent root
canal sealer |
| Intended Use | For use, as a temporary or
permanent root canal sealer, 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.
Intended for use by qualified
healthcare personnel trained in its
use. | For use, as a temporary or
permanent root canal sealer, 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
puipectomy, 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.
Intended for use by qualified
healthcare personnel trained in its
use. |
| Human
Factors | Dispensed ready to use | Dispensed ready to use |
| Similar
Physical
Properties | ISO 6876 Fluidity, Working Time,
Film Thickness, Radiopacity,
Solubility & disintegration | ISO 6876 Fluidity, Working Time,
Film Thickness, Radiopacity,
Solubility & disintegration |

2

| | Metapex | Vitapex Pre-Loaded Dental
Syringe |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | Freedom from toxicity per ISO/TR
7405 Agar diffusion test | Freedom from toxicity per ISO/TR
7405 Agar diffusion test |
| | Biocompatible per ISO 10993-11
Acute intervenous application | Biocompatible per ISO 10993-11
Acute intervenous application |
| Design,
Construction,
Components | Premixed paste, packaged in
plastic syringe ready to be
dispensed through disposable tips
into root canal | Premixed paste, packaged in
plastic syringe ready to be
dispensed through disposable tips
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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 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