(96 days)
Not Found
No
The summary describes a calcium hydroxide paste for root canal filling and does not mention any AI or ML components or functionalities.
Yes
The device is described as a "root canal filling used for the temporary filling of root canals after endodontic surgery," which indicates a therapeutic purpose.
No
Metapaste Plus is a temporary filling material used after endodontic surgery and for vital pulpotomy. Its function is to fill root canals and its "state of the treatment can be confirmed by the radiopacity of barium sulfate contained," which implies monitoring the treatment's progression rather than diagnosing a condition. It treats a condition, it does not diagnose one.
No
The device description clearly states it is a "water-based calcium hydroxide paste material" and is "pre-mixed in a syringe," indicating it is a physical substance and delivery mechanism, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary filling of root canals after endodontic surgery" and "vital pulpotomy in deciduous teeth." This is a direct therapeutic application within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a material applied directly to the root canal, not a reagent or instrument used to analyze biological samples.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, measure a substance in a sample, or provide information for diagnostic purposes.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. Metapaste Plus is a material used in the body for a therapeutic purpose.
N/A
Intended Use / Indications for Use
Metapaste Plus is a biocompatible root canal filling used for the temporary filling of root canals after endodontic surgery. Metapaste Plus can be used on its own and for vital pulpotomy in deciduous teeth.
Metapaste 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
Metapaste Plus is a water-based calcium hydroxide paste material for root canal temporary filling. It is pre-mixed in a syringe for convenient delivery in the root canal. When applied to root canal, it is alkaline by calcium hydroxide. The state of the treatment can be confirmed by the radiopacity of barium sulfate contained. Also, it is water-soluble and easy to remove.
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
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:
- Performance testing of Appearance, Weight, Packaging according to Manufacturer standard.
- Performance testing of Flowability and Radio-opacity according to ISO 6876:2012.
- Biocompatibility Tests according to EN ISO 10993-1:2009, EN ISO 10993-3:2014, EN ISO 10993-5:2009, EN ISO 10993-6:2009, EN ISO 10993-10:2013, EN ISO 10993-11:2017.
- Shelf Life test: Manufacturer standard tests (Appearance, Packaging), ISO 6876:2012 tests (Flowability, Radio-opacity)
Key Results:
- Flowability: 21mm (meets ISO 6876 requirement > 17mm)
- Radio-opacity: 3.1mm (meets ISO 6876 requirement of not less than 3 mm of aluminium)
- Biocompatibility: Yes (proved by performing tests in accordance with ISO 10993-1)
- Shelf Life: 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.
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.
K032605, Metapaste by Meta Biomed Co., Ltd.
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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
June 30, 2021
Meta Biomed Co., Ltd. April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K210904
Trade/Device Name: Metapaste Plus Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: March 15, 2021 Received: March 26, 2021
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.
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
1
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 (OS) 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,
Michael E. Adjodha, M.ChE. 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)
K210904
Device Name Metapaste Plus
Indications for Use (Describe)
Metapaste Plus is a biocompatible root canal filling used for the temporary filling of root canals after endodontic surgery. Metapaste Plus can be used on its own and for vital pulpotomy in deciduous teeth.
Metapaste 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 201 Subpart D) |
| Over-The-Counter Use (21 CFR 201 Subpart C) |
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 above and to the right of the "A". Below "META" 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
510(k) Summary K210904
Submitter
META BIOMED CO., LTD. Suk Song Oh 270, Osongsaengmyeong 1-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, South Korea 28161 Email: ef1459@meta-biomed.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: Metapaste Plus
- Classification Name: Resin, Root Canal Filling .
- Product Code: KIF
- Panel: Dental
- Regulation Number: 21 CFR 872.3820
- Device Class: Class II
- Date prepared: 03/15/2021
Predicate Devices:
Primary Predicate
- . K032605, Metapaste by Meta Biomed Co., Ltd.
Device Description
Metapaste Plus is a water-based calcium hydroxide paste material for root canal temporary filling. It is pre-mixed in a syringe for convenient delivery in the root canal. When applied to root canal, it is alkaline by calcium hydroxide. The state of the treatment can be confirmed by the radiopacity of barium sulfate contained. Also, it is water-soluble and easy to remove.
Indication for Use
Metapaste Plus is a biocompatible root canal filling used for the temporary filling of root canals after endodontic surgery. Metapaste Plus can be used on its own and for vital pulpotomy in deciduous teeth. Metapaste Plus is intended for use by qualified healthcare personnel trained in its use.
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 word "META" above the word "BIOMED" on the right. The tooth icon is divided horizontally, with the top half in dark blue and the bottom half in teal. The words "META" and "BIOMED" are also in dark blue and teal, respectively, with a registered trademark symbol next to the word "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
E-mail
info@meta-biomed.com http://www.meta-biomed.com
Summary of Technological Characteristics:
| Subject Device | Predicate Device | |
|---|---|---|
| Manufacturer | Meta Biomed Co., Ltd. | Meta Biomed Co., Ltd. |
| Device Name | Metapaste Plus | Metapaste |
| 510(k) Number | NA | K032605 |
| 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 | Metapaste Plus is a biocompatible root | |
| canal filling used for the temporary filling | ||
| of root canals after endodontic surgery. | ||
| Metapaste Plus can be used on its own | ||
| and for vital pulpotomy in deciduous | ||
| teeth. | ||
| Metapaste Plus is intended for use by | ||
| qualified healthcare personnel trained in | ||
| its use. | Metapaste is a biocompatible root canal | |
| sealer used for the temporary filling of | ||
| root canals after endodontic surgery. | ||
| Metapaste can be used on its own and | ||
| for vital pulpectomies in deciduous | ||
| teeth. | ||
| Metapaste is intended for use by | ||
| qualified healthcare personnel trained in | ||
| its use. | ||
| Raw Material | Calcium hydroxide | |
| Barium sulfate | ||
| Aluminum oxide | ||
| Titanium oxide | ||
| Polyethylene glycol | ||
| Dihydrogen oxide | Calcium hydroxide | |
| Barium sulfate | ||
| Polypropylene glycol | ||
| Principle of Operation | Metapaste Plus is a biocompatible root | |
| canal sealer used for the temporary filling | ||
| of root canals after endodontic surgery. | Metapaste is a biocompatible root canal | |
| sealer used for the temporary filling of | ||
| root canals after endodontic surgery. | ||
| Performance Standard | ||
| Conformance | Conformed to ISO 6876 | Conformed to ISO 6876 |
| Flowability | 21mm | 12mm |
| Radio-opacity | 3.1mm | 3.4mm |
| Biocompatibility | Yes | Yes |
| Sterility | Non-sterile | Non-sterile |
| Shelf Life | 2 years | 2 years |
5
Image /page/5/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. Below "META" is the text "BIOMED" in teal. The logo is simple and modern, and the colors are clean and professional.
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
The subject device and the primary predicate have the similar indications, principle of operation, technological characteristics and 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.
Compared to the primary predicate, Indications for Use, flowability, Radio-opacity and material of the subject device are different.
| 1) Indications for Use | ||
|---|---|---|
| Metapaste Plus | Metapaste (K032605) | Discussion |
| Metapaste Plus is a | ||
| biocompatible root canal | ||
| filling used for the | ||
| temporary filling of root | ||
| canals after endodontic | ||
| surgery. Metapaste Plus | ||
| can be used on its own and | ||
| for vital pulpotomy in | ||
| deciduous teeth. | ||
| Metapaste Plus is intended | ||
| for use by qualified | ||
| healthcare personnel | ||
| trained in its use | Metapaste is a biocompatible root | |
| canal sealer used for the | ||
| temporary filling of root canals | ||
| after endodontic surgery. | ||
| Metapaste can be used on its own | ||
| and for vital pulpectomies in | ||
| deciduous teeth. | ||
| Metapaste is intended for use by | ||
| qualified healthcare personnel | ||
| trained in its use | subject device (Metapaste plus) and predicate | |
| device (Metapaste) are temporary root canal | ||
| filling materials. The Indication for Use of subject | ||
| device (Metapaste Plus) and predicate device | ||
| (Metapaste) has same contents. In the Metapaste | ||
| Plus Indication for Use, there is content of | ||
| pulpotomy that is not found in Indication of use of | ||
| Metapaste. | ||
| It is a technique commonly used of temporary root | ||
| canal fillings and as such does not affect the | ||
| equivalence of Indication of subject and predicate | ||
| devices. |
-
- The flowability between the subject and primary predicate is different; however, the flow of dental root canal filling material shall be more than 17mm in accordance with ISO 6876: 2012 test method, which is the subject device's flowability value meet the ISO 6876 requirements. Therefore, this difference doesn't impact the clinical performance of the product and substantial equivalence.
-
- The Radio-opacity between the subject and primary predicate is different; however, the Radioopacity of dental root canal filling material shall have a radio opacity equivalent to not less than 3 mm of aluminium in accordance with ISO 6876: 2012 test method, which is the subject device's Radio-opacity value meet the ISO 6876 requirements. Therefore, this difference doesn't impact the clinical performance of the product and substantial equivalence.
-
- The raw materials of subject device and the predicate device have a little difference in specific components and their composition. However, both products belong to calcium hydroxide paste. demonstrating their clinical safety and the biocompatibility of subject device has been proved by performing tests required for evaluating its biocompatibility in accordance with ISO10993-1. For this reason, although there is difference of raw materials between subject device and predicate device, it does not affect the clinical safety of subject device.
6
Image /page/6/Picture/0 description: The image contains a 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 split into two colors, with the top half being a dark blue and the bottom half being a teal color. The words "META" and "BIOMED" are also in teal, and there is a registered trademark symbol next to the word "META".
Address
270, Osongsaengmyeong 1-ro,
Osong-eup, Heungdeok-gu,
Cheongju-si, Chungcheongbuk-do,
Korea
+82-43-216-0433 +82-43-217-1988
Tol
Non-clinical Testing
The following testing was conducted on our subject device:
- Performance testing of Appearance, Weight, Packaging according to Manufacturer standard. o
- Performance testing of Flowability and Radio-opacity according to ISO 6876:2012.
- . Biocompatibility Tests according to EN ISO 10993-1:2009, EN ISO 10993-3:2014, EN ISO 10993-5:2009, EN ISO 10993-6:2009, EN ISO 10993-10:2013, EN ISO 10993-11:2017.
- Shelf Life test: Manufacturer standard tests (Appearance, Packaging), ISO 6876:2012 tests ● (Flowability, Radio-opacity)
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.