(100 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of a root canal sealer, with no mention of AI or ML.
No
The device is a root canal sealer, used to seal root canals, and does not perform a therapeutic function beyond sealing.
No
Explanation: The device is a root canal sealing material and is used for treatment, not for diagnosing a condition.
No
The device is a physical substance (two-component paste) used for root canal sealing, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "root canal sealing of root canals following established endodontic procedures." This is a therapeutic and restorative procedure performed directly on the patient's anatomy.
- Device Description: The device is a "two component paste device based upon epoxy-amine resin chemistry" used for sealing root canals. This is a material applied to the patient's tooth.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, analyze a sample from the human body, or provide information about a patient's health status.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
ADSEAL Plus is a biocompatible root canal 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 Plus 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
ADSEAL Plus root canal sealer is a two component 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 two components, the epoxy resin paste (Paste A) and the amine-containing 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 Plus 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 (dental)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified healthcare personnel trained in its use.
Dentist
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)
Non-clinical Testing:
- Biocompatibility Tests according to ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017.
- Performance tests such as extraneous matter and package according to ISO 6876:2012.
- Shelf Life test: ISO 6876 tests (setting time, flow and Solubility).
Key results:
- Flowability: 31mm
- Radio-opacity: 4.25mm
- Biocompatibility: Yes
- Sterility: Non-sterile
- Shelf Life: 2 years
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flowability: 31mm
Radio-opacity: 4.25mm
Biocompatibility: Yes
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.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 13, 2023
Meta Biomed Co., LTD. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K230010
Trade/Device Name: ADSEAL Plus Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: February 13, 2023 Received: February 13, 2023
Dear April Lee:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Bobak Shirmohammadi
-5
For Michael Adjodha, M.ChE.,CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230010
Device Name ADSEAL Plus
Indications for Use (Describe)
ADSEAL Plus is a biocompatible root canal 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 Plus is intended for use by qualified healthcare personnel trained in its use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image shows the logo for META BIOMED. The logo consists of a stylized tooth shape on the left, with the top half in dark blue and the bottom half in teal. To the right of the tooth shape is the text "META" in dark blue, with a registered trademark symbol next to it, and below that is the text "BIOMED" in teal.
Address
270, Osongsaengmyeong 1-ro,
Osong-eup, Heungdeok-gu,
Cheongju-si, Chungcheongbuk-do,
Korea
Tel
+82-43-216-0433
Fax
+82-43-217-1988
METABIOMED CO.,LTD
E-mail
info@meta-biomed.com
http://www.meta-biomed.com
K230010 10(k) Summary
Submitter META BIOMED CO., LTD. Suk Song Oh 270, Osongsaengmyeong 1-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, South Korea Email: ef1459(@metabiogw.bizmeka.com Phone: +82-43-230-8841 Fax: +82-43-217-1983
Official Correspondent
Withus Group Inc April Lee 106 Superior, Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122
Device Information
- Trade Name: ADSEAL Plus ●
- Classification Name: resin, root canal filling
- . Product Code: KIF
- Panel: Dental ●
- Regulation Number: 21 CFR 872.3820
- Device Class: Class II
- . Date prepared: 01/03/2023
Predicate Devices:
- K042769, ADSEAL ROOT CANAL SEALER by Meta Biomed Co., Ltd. ●
Device Description
ADSEAL Plus root canal sealer is a two component 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 two components, the epoxy resin paste (Paste A) and the amine-containing 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 Plus device is similar in design, materials and intended use to other 510(k) cleared devices which are in commercial distribution.
4
Image /page/4/Picture/0 description: The image shows the logo for META BIOMED. The logo consists of a stylized tooth icon on the left, with the text "META BIOMED" to the right. The tooth icon is divided into two colors, with the top half in dark blue and the bottom half in light blue. The text "META" is in dark blue, while "BIOMED" is in light blue, and there is a registered trademark symbol next to META.
Address
270, Osongsaengmyeong 1-ro,
Osong-eup, Heungdeok-gu,
Cheongju-si, Chungcheongbuk-do,
Korea
Tel
+82-43-216-0433
Fax
+82-43-217-1988
Indication for Use
ADSEAL Plus 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 Plus is intended for use by qualified healthcare personnel trained in its use.
Non-clinical Testing
The following testing was conducted on our subject device:
- . Biocompatibility Tests according to ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017.
- . Performance tests such as extraneous matter and package according to ISO 6876:2012.
- Shelf Life test: ISO 6876 tests (setting time, flow and Solubility) .
Summary of Technological Characteristics:
The subject device and the predicate device have the same intended use and have the similar technological characteristics and are made of similar materials. They encompass the same range of physical and chemical properties. The subject device and predicate devices are packaged in similar material and use similar methods of application.
The subject device is different from the predicate devices in raw materials, however, the test results provided in this submission supports that it is substantially equivalent to the predicate device.
| Subject Device | Predicate Device | |
|---|---|---|
| Manufacturer | Meta Biomed Co., Ltd. | Meta Biomed Co., Ltd. |
| Device Name | ADSEAL Plus | Adseal |
| 510(k) Number | N/A | K042769 |
| Classification | ||
| Name | resin, root canal filling | resin, root canal filling |
| Product Code | KIF | KIF |
| Regulation | ||
| Number | 21 CFR 872.3820 | 21 CFR 872.3820 |
| Indications for use | ADSEAL Plus 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 Plus is intended for use by qualified
healthcare personnel trained in its 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. |
5
Image /page/5/Picture/0 description: The image shows the logo for Meta Biomed. The logo consists of a stylized tooth icon on the left, with the word "META" above the word "BIOMED" on the right. The tooth icon is divided horizontally into two colors, with the top half being a dark blue and the bottom half being a teal color. The word "META" is also in dark blue, while the word "BIOMED" is in teal.
ongbuk-do,
Tel +82-43-216-0433 +82-43-217-1988
METABIOMED CO.LTD.
E-mail info@meta-biomed.com http://www.meta-biomed.com
| Base | Base | |
|---|---|---|
| Raw Material | 1. Poly(Bisphenol A-co-epichlorohydrin), | |
| glycidyl end-capped |
- 2-Hydroxyethyl salicylate
- Zirconium Dioxide
- Calcium Phosphate
Catalyst
- Poly(1,4-butanediol)
bis(4-aminobenzoate) - 1,3-benzenedimethan amine
- Poly(propylene glycol)
bis(2-aminopropyl ether) - Triethanolamine
- Zirconium Dioxide
- Calcium Phosphate
- Calcium Oxide
- Ferric Oxide Hydrate
(Yellow Iron Oxide) | 1. Poly(Bisphenol-A-co-
epichlorohydrin), glycidyl end capped - Ethylene glycol monosalicylate
- Calcium phosphate
- Bismuth subcarbonate
- Zirconium oxide
Catalyst
- Poly(1,4-butanediol)
Bis(4-aminobenzoate) - Triethanolamine
- Calcium phosphate
- Bismuth Subcarbonate
- Zirconium oxide
- Calcium oxide |
| Principle of
Operation | ADSEAL Plus is a root canal filler sealer that
is completely mixed with a root canal filling
resin sealer used for dental treatment and is
used together with a sealing point (gertera
differential) to permanently fill the root canal. | ADSEAL is a root canal filler sealer that
is completely mixed with a root canal
filling resin sealer used for dental
treatment and is used together with a
sealing point (gertera differential) to
permanently fill the root canal. |
| Performance
Standard | Conformed to ISO 6876 | Conformed to ISO 6876 |
| Flowability | 31mm | 44mm |
| Radio-opacity | 4.25mm | 5.44mm |
| Biocompatibility | Yes | Yes |
| Intended Operator | Dentist | Dentist |
| Sterility | Non-sterile | Non-sterile |
| Shelf Life | 2 years | 2 years |
Conclusion:
Based on documentation supplied with this submissions drawn from the testing results demonstrate that the subject device is substantially equivalent to our legally marketed predicate device.