ADSEAL ROOT CANAL SEALER

K042769 · Meta Biomed Co., Ltd. · KIF · Nov 24, 2004 · Dental

Device Facts

• Record ID: K042769
• Device Name: ADSEAL ROOT CANAL SEALER
• Applicant: Meta Biomed Co., Ltd.
• Product Code: KIF · Dental
• Decision Date: Nov 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

Adseal is a biocompatible root canal sealer for permanent sealing of root canals following established endodontic procedures and may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points). Adseal is intended for use by qualified healthcare personnel trained in its use.

Device Story

Adseal is a two-component epoxy-amine resin root canal sealer; supplied in a dual-chamber plastic syringe with disposable applicator. Components (Paste A: epoxy resin; Paste B: amine) are mixed prior to insertion into prepared root canal. Device adapts to canal walls; provides long-term dimensional stability; minimal shrinkage upon setting. Used by dentists/endodontists in clinical settings during root canal procedures. Output is a set, biocompatible seal within the tooth structure. Benefits include permanent sealing of root canal space to prevent reinfection.

Clinical Evidence

Bench testing only. Performance evaluated against ISO 6876 standards for dental root canal sealing materials, including fluidity, working time, film thickness, radiopacity, and solubility/disintegration. Biocompatibility confirmed via ISO/TR 7405 agar diffusion testing.

Technological Characteristics

Two-component epoxy-amine resin paste system. Packaged in dual-chamber plastic syringe. Complies with ISO 6876 for dental root canal sealing materials. Biocompatible per ISO/TR 7405. No electronic components or software.

Indications for Use

Indicated for permanent sealing of root canals following established endodontic procedures in patients requiring root canal therapy; may be used with auxiliary materials like gutta percha points. 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

• Bi-Directional Spiral & Epoxy Root Canal Cement System (K992727)
• Dentsply AH Plus Root Canal Sealer (K960548)
• Dentsply AH 26 Root Canal Sealer

Submission Summary (Full Text)

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- l 510(k) Summary
K042769

# NOV 2 4 2004

- 1.1 Date of Summary Preparation: March 24, 2004 1.2 Manufacturers Contact Person: Jenny Sohn, Official Correspondent TEL [phone]
FAX [phone] Meta Dental Co. 82-06 Grand Avenue Elmhurst, NY 11373

- 1.3 Name

| Trade Name: | Adseal |
|--------------|-------------------|
| Common Name: | Root Canal Sealer |

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

| Classification Name | Product Code | 111<br>Class | 21CFR 8 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|----------|
| Canal Filling Resin | VIC | | 070 7000 |
| Koot | 1, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, | | -- 3020 |

# 1.5 Standards/Special Controls:

ISO 6876 Dental root canal sealing materials.

### 1.6 Indications for Use:

Adseal is a biocompatible root canal sealer for permanent sealing of root canals following established endodontic procedures and may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points).

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

### 1.7 Device Description:

Adseal root canal sealer is a two component paste:paste device based upon epoxy-amine resin chemistry. This sealer is easy to mix and adapts closely to the walls of the prepared root canal and provides outstanding long-term dimensional stability with minimal shrinkage upon setting.

The device consists of tow components, the epoxy resin paste (Paste A) and the aminecontaining paste (Paste B); portions of which are mixed prior to insertion into the root canal. This two component system reacts via an epoxide-amine chemical reaction to cause setting. It may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points).

SKIS
DE
II
5

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Paste A and Paste B are contained, separately, with the chambers of a two component plastic syringe, packaged with a disposable applicator.

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

### 1.8 Substantially Equivalent Commercially Available Devices:

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

Bi-Directional Spiral & Epoxy Root Canal Cement System K992727 Dentsply AH Plus Root Canal Sealer K960548 Dentsply AH 26 Root Canal Sealer (Pre- Amendment Device)

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

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# Substantial Equivalence Comparisor 1.9

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

| Labelling | | Intended Use | Human Factors | Similar Physical Properties | | Adseal | MDS<br>Bi-Directional Spiral<br>& Epoxy Root Canal<br>Cement System | Dentsply<br>AH 26 | Dentsply<br>AH Plus | |
|-----------|---------------------------------------------------------------|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-------------------------------------------------------------------------------------------|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| | Adseal | Permanent root canal sealer | For permanent sealing of root canals following established endodontic procedures and may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points).<br>Intended for use by qualified healthcare personnel trained in its use. | Mixed, two part system | ISO 6876 Fluidity, Working Time, Film Thickness, Radiopacity, Solubility & disintegration | Biocompatibility | Freedom from toxicity per<br>ISO/TR 7405 Agar<br>diffusion test | Biocompatible | Biocompatible | Biocompatible |
| | MDS<br>Bi-Directional Spiral & Epoxy Root Canal Cement System | Permanent root canal sealer | For permanent sealing of root canals following established endodontic procedures.<br>Intended for use by qualified healthcare personnel trained in its use. | Mixed, two part system | ISO 6876 Fluidity, Working Time, Film Thickness, Radiopacity, | Design,<br>Construction,<br>Components | Biocompatible per ISO<br>10993-11 Acute<br>intervenous application<br>Premixed, two part paste,<br>packaged in two<br>component plastic<br>syringe ready to be<br>dispensed and mixed | Premixed, two part<br>powder/liquid-gel,<br>packaged and ready to<br>be dispensed and<br>mixed | Premixed, two part<br>powder/liquid-gel,<br>packaged in a bottle<br>and tube ready to be<br>dispensed and mixed | Premixed, two part<br>paste, packaged in two<br>individual tubes ready<br>to be dispensed and<br>mixed |
| | Dentsply AH 26 | Permanent root canal sealer | For permanent sealing of root canals following established endodontic procedures and may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points).<br>Intended for use by qualified healthcare personnel trained in its use. | Mixed, two part system | ISO 6876 Fluidity, Working Time, Film Thickness, Radiopacity, | | | | | |
| | Dentsply AH Plus | Permanent root canal sealer | For permanent sealing of root canals following established endodontic procedures and may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points).<br>Intended for use by qualified healthcare personnel trained in its use. | Mixed, two part system | ISO 6876 Fluidity, Working Time, Film Thickness, Radiopacity, | | | | | |

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### 1.10 Indications and Contraindications:

Relative indications and contraindications for Adseal 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, Adseal root canal sealer, is safe, effective and substantially equivalent to the predicate device as described herein.

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Image /page/5/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 2004

Meta Biomed Company Limited C/O Mr. Ned Devine Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue SE Grand Rapids, Michigan 49548-1289

Re: K042769

Trade/Device Name: Adseal Root Canal Filling Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: November 10, 2004 Received: November 12, 2004

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 (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" (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,

Chris L

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

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# Indications for Use

# 510(k) Number (if known): K042769

Device Name : Adseal Root Canal Filling

# Indications for Use:

Adseal is a biocompatible root canal sealer for permanent sealing of root canals following established endodontic procedures and may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points)

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

Prescription Use
(Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use_ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

| 510(k) Number | R042769 |
|---------------|---------|
|---------------|---------|

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