For fabrication of temporary fillings and other temporary prosthetics for use until the permanent prosthetic is ready for insertion. intended to temporarily restore carious lesions or structural defects in teeth. Intended for use in cavities, Class I, II, III, IV (inlays and onlays).

Device Description

MD-Temp Plus is used for temporary filling material. It is supplied in a 20, 30 or 40g jar in either white (tooth-like) or pink (gum-like), and individually boxed. It is intended primarily as a temporary filling material for most cavities or damages but may be used by the dentist for other temporary restorations. MD-Temp plus is water-based temporary filling materials used for part of a tooth or multiple teeth. The curing reaction is the hydration reaction of the gypsum, and the semi-gypsum is cured as it is exposed to saliva or water in the oral cavity.

AI/ML Overview

This document is a 510(k) Premarket Notification for a dental temporary filling material called MD-Temp Plus. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, MD-Temp. The document details non-clinical testing performed to establish safety and effectiveness.

Based on the provided text, it's important to note that this submission is for a dental material (a physical device), not an Artificial Intelligence/Machine Learning (AI/ML) powered medical device. Therefore, many of the requested criteria related to AI/ML device performance (like MRMC studies, human reader improvement with AI, training set details, and expert consensus for ground truth) are not applicable to this type of device submission.

The acceptance criteria and study proving the device meets them are based on physical and chemical performance standards for dental materials, and biocompatibility testing.

Here's an analysis of the provided information, addressing the applicable points:

Acceptance Criteria and Study for MD-Temp Plus (Dental Temporary Filling Material)

This submission focuses on demonstrating substantial equivalence of a new dental material (MD-Temp Plus) to a previously cleared material (MD-Temp) through non-clinical performance and biocompatibility testing. The "acceptance criteria" are the relevant ISO and ASTM standards for such materials, and the "study" involves conducting tests to ensure the device performs within acceptable parameters defined by these standards.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device was tested to evaluate its safety and effectiveness according to various standards. While it explicitly lists standards for Biocompatibility, Shelf Life, Compressive Strength, and Setting Time, and mentions others for Flexural Strength and Tensile Strength, it does not provide specific numerical "acceptance criteria" directly from these standards within the document. Instead, it presents the measured performance of both the subject and predicate devices and states that the improvements in the subject device's performance (setting time and compressive strength) are "within the range of the test standards and it doesn't affect the safety and effectiveness."

Here's a table summarizing the reported device performance and the related, implied acceptance criteria based on standard compliance:

Performance Metric	Reported Device Performance (MD-Temp Plus)	Reported Predicate Performance (MD-Temp)	Implied Acceptance Criteria (Based on Standard Compliance)
Biocompatibility	Compliant with ISO 10993-1, -5, -10, -11	Compliant with ISO 10993-1, -5, -10, -11	Must meet biocompatibility requirements of ISO 10993 series for dental materials (e.g., non-cytotoxic, non-irritating, non-sensitizing, non-toxic). Details not provided in text.
Appearance, Weight, Packaging	Tested	Not explicitly stated	Must meet internal specifications and quality control for appearance, weight, and packaging integrity.
Shelf Life	3 years	2 years	Must demonstrate stability and performance for the claimed shelf life (tested per ASTM F1980). A 3-year shelf life demonstrably superior to predicate.
Compressive Strength	2.2 MPa	6.5 MPa	Tested according to ISO 3107:2011. While the subject device's strength is lower than the predicate, the document asserts it's "within the range of the test standards" and does not affect safety/effectiveness. Specific minimum threshold from ISO 3107 is not provided.
Setting Time	27 min	55 min	Tested according to ISO 3107:2011. Faster setting time is an improvement. The document states it's "within the range of the test standards" and does not affect safety/effectiveness. Specific range from ISO 3107 is not provided.
Flexural Strength	Compared	Not explicitly stated	Tested according to ISO 4049:2009. Must meet standard requirements.
Tensile Strength	Compared	Not explicitly stated	Tested according to ANSI/ADA 27:1977. Must meet standard requirements.
Acid Soluble Arsenic	Not detected	0.075	Must be within acceptable limits for dental materials. "Not detected" is superior to predicate.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample sizes (e.g., number of specimens) used for each of the physical and chemical tests (compressive strength, setting time, etc.). These numbers would typically be defined by the respective ISO/ASTM standards.
Data Provenance: The testing was conducted by Meta Biomed Co., Ltd. (the manufacturer) in South Korea, as indicated by the company's address. The data appears to be prospective as it was generated specifically for this 510(k) submission to demonstrate the performance of the MD-Temp Plus device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not Applicable. For this type of physical/chemical material testing, "ground truth" is established by adherence to standardized test methods (e.g., ISO, ASTM standards) and measurements conducted in accredited laboratories. It does not involve human experts in the way AI/ML performance evaluation does (e.g., radiologists interpreting images).

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (like 2+1, 3+1 consensus) are used for resolving disagreements in human expert interpretations, particularly in medical image analysis. For material testing, results are typically quantitative measurements, and repeatability/reproducibility are ensured through standardized protocols and calibration.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. An MRMC study is designed for evaluating the impact of AI on human readers in diagnostic tasks, typically involving medical imaging. This is a physical dental material, so such a study is irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This is not an AI algorithm. Its "performance" is its physical and chemical properties as measured by the non-clinical tests.

7. The Type of Ground Truth Used

For physical and chemical properties (e.g., setting time, compressive strength): The ground truth is the measured value obtained through standardized laboratory testing procedures (e.g., ISO 3107, ISO 4049, ANSI/ADA 27) using calibrated equipment.
For biocompatibility: The ground truth is determined by the results of specific biological assays (e.g., cytotoxicity, sensitization, irritation tests) as outlined in the ISO 10993 series.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device that requires a "training set." The device is manufactured based on a defined material composition and manufacturing process, and its performance is validated through testing of manufactured lots.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set for an AI/ML model, there is no ground truth establishment for such a set. The "ground truth" during product development (analogous to training for AI) would be the desired material properties and how to achieve them through formulation and manufacturing, which is part of the R&D process prior to formal validation testing.

Summary

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July 3, 2019

Meta Biomed Co., Ltd % April Lee Consultant Withus Group Inc 106 Superior Irvine. California 92620

Re: K190724

Trade/Device Name: MD-Temp Plus Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: Class II Product Code: EBG Dated: April 5, 2019 Received: April 10, 2019

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.

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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 medical devices and radiation-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.

Srinivas Nandkumar, PhD Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190724

Device Name MD-Temp Plus

Indications for Use (Describe)

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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510(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: MD-Temp Plus ●
Classification Name: Crown And Bridge, Temporary, Resin ●
Product Code: EBG ●
Panel: Dental ●
Regulation Number: 21 CFR 872.3770 ●
Device Class: Class II
. Date prepared: 06/26/2019

Predicate Devices:

Primary Predicate

K061530, MD-TEMP manufactured by Meta Biomed Co., Ltd. -

Device Description

Indication for Use

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Non-clinical Testing

The subject device was tested to evaluation its safety and effectiveness according to the following standards:

Biocompatibility Tests according to ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010, -ISO 10993-11:2006.
-Performance tests such as appearance, weight, packaging
Shelf Life tests according to the ASTM F1980 -
Compressive Strength testing according to ISO 3107: 2011 -
-Setting time testing according to ISO 3107: 2011
-Compared Flexural Strength Test according to the ISO 4049:2009
Compared Tensile Strength Test according to the ANSI/ADA 27:1977 -

Summary of Technological Characteristics:

The subject device and predicate device have same Indications for use and principle of operation and similar technological characteristics and testing standards.

Some technological characteristics such as setting time and compressive strength are different between the subject and primary predicate, however, it is to improve the device's performance. Both test results are within the range of the test standards and it doesn't affect the safety and effectiveness.

	Subject Device	Primary Predicate
Manufacturer	META BIOMED CO., LTD.	META BIOMED CO., LTD.
Device Name	MD-Temp Plus	MD-Temp
510(k) Number	NA	K061530
ClassificationName	Crown And Bridge, Temporary, Resin	Crown And Bridge, Temporary, Resin
Product Code	EBG	EBG
RegulationNumber	21 CFR 872.3770	21 CFR 872.3770
Indications forUse	For fabrication of temporary fillings andother temporary prosthetics for use untilthe permanent prosthetic is ready forinsertion. intended to temporarily restorecarious lesions or structural defects inteeth. Intended for use in cavities, ClassI, II, III, IV (inlays and onlays).	For fabrication of temporary fillingsand other temporary prosthetics for useuntil the permanent prosthetic is readyfor installation. Intended to restorecarious lesions or structural defects inteeth temporarily. Intended for use incavities Classes I, II, III, IV (inlaysand onlays) and as a restorativematerial for veneers, crowns, andbridges.

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Principle ofoperation	The main curing reaction of temporaryfilling materials is represented by thehydration reaction of gypsum.	The main curing reaction of temporaryfilling materials is represented by thehydration reaction of gypsum.
MaterialComposition	-Vinyl Chloride Vinyl AcetateCopolymer-Bis(2-ethylhexyl) Adipate-Zinc Oxide-Calcium Sulfate Hemihydrate-Menthol Oil-D&C Red 6	- Polyvinyl acetate- Zinc oxide- Zinc sulfate- Ethanol- Dye (Red)
Setting Time	27 min	55 min
CompressiveStrength	2.2 MPa	6.5 MPa
Acid solublearsenic contents	Not detected	0.075
Shelf Life	3 years	2 years
PerformingTesting	Tested according to ISO 3107	Tested according to ISO 3107
BiocompatibilityTesting	Testing according to ISO-10993-1; -5; -10; -11	Testing according to ISO-10993-1; -5; -10; -11

Similarities -

The subject device and the predicate device have the same indications for use, principle of operations and were tested in accordance with the same testing standards such as ISO 3107 and ISO10993.

Differences -

1. Material Composition
  Compared to the primary predicate, some materials of the subject device have been changed as following:

Ingredients fromPrimary predicate	Ingredients fromSubject device	Functions in the devices(Equivalent)
Polyvinyl acetate	Vinyl Chloride - Vinyl AcetateCopolymer	Viscosity modifier
Ethanol	Bis(2-ethylhexyl) Adipate	Diluent
Zinc oxide	Zinc oxide	Filler
Zinc sulfate	Calcium Sulfate hemihydrate	Curing material

The raw materials are different between two devices but their roles and functions are the same. Therefore, overall, the raw materials of two devices are similar.

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Setting Time and Compressive Strength

Performance characteristics have changed to improve setting time and compressive strength. This difference in performance doesn't affect any safety and effectiveness in clinical practice.

3. Shelf Life

The shelf life of the subject device is 3 years and the shelf life of the predicate device is 2 years.

1. Indications for Use
  Even though the indications for use of our subject device and predicate device are different, it doesn't affect product's substantial equivalence since the indications of the subject device is in the range of the indications of the predicate device.

In conclusion, it can be regarded as equivalent when the indications for use, raw materials, working principle and performance are compared.

Conclusion:

The subject and predicate device are similar in indications for use and intended use. After testing for safety and function Meta Biomed Co., Ltd concludes that the improvements to function in setting time and compressive strength do not introduce any new issues and the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.