(50 days)
No
The device description focuses on the chemical composition and physical properties of a root canal sealer, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are also marked as "Not Found".
No
The device is a root canal sealer, which is used for permanent sealing of root canals. While it aids in the success of a dental procedure, it does not directly treat a disease or condition; rather, it provides a sealing function within the tooth after other therapeutic actions (like cleaning and shaping the root canal) have been performed.
No
Explanation: The device is a root canal sealer, which is a therapeutic material used for permanent sealing of root canals, not for identifying or diagnosing a condition.
No
The device description clearly states it is a two-component paste:paste device based on epoxy-amine resin chemistry, consisting of physical components (Paste A and Paste B) and a syringe with an applicator. This indicates a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "permanent sealing of root canals following established endodontic procedures." This is a therapeutic and restorative procedure performed directly on a patient's tooth, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is a "two component paste:paste device based upon epoxy-amine resin chemistry" that is mixed and inserted into the root canal. This describes a material used for sealing and filling, not for analyzing a biological sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition
- Using reagents or assays to detect or measure substances
In summary, Adseal is a dental material used for a therapeutic procedure within the body, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / 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.
Product codes
VIC, KIF
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).
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.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
- 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 (718)-639-7460
FAX (718)-639-7408 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
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
1
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.
2
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
Bi-Directional Spiral
& Epoxy Root Canal
Cement System | Dentsply
AH 26 | Dentsply
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).
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
ISO/TR 7405 Agar
diffusion test | Biocompatible | Biocompatible | Biocompatible |
| | MDS
Bi-Directional Spiral & Epoxy Root Canal Cement System | Permanent root canal sealer | For permanent sealing of root canals following established endodontic procedures.
Intended for use by qualified healthcare personnel trained in its use. | Mixed, two part system | ISO 6876 Fluidity, Working Time, Film Thickness, Radiopacity, | Design,
Construction,
Components | Biocompatible per ISO
10993-11 Acute
intervenous application
Premixed, two part paste,
packaged in two
component plastic
syringe ready to be
dispensed and mixed | Premixed, two part
powder/liquid-gel,
packaged and ready to
be dispensed and
mixed | Premixed, two part
powder/liquid-gel,
packaged in a bottle
and tube ready to be
dispensed and mixed | Premixed, two part
paste, packaged in two
individual tubes ready
to be dispensed and
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).
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).
Intended for use by qualified healthcare personnel trained in its use. | Mixed, two part system | ISO 6876 Fluidity, Working Time, Film Thickness, Radiopacity, | | | | | |
3
4
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.
5
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.
6
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 (240) 276-0115. 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,
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
7
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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