(105 days)
No
The device description and performance studies focus on material properties and physical characteristics, with no mention of AI or ML.
No
The device is a temporary filling material used to restore carious lesions or structural defects in teeth, rather than treating a disease or condition.
No
The device is a temporary filling material used for restorative purposes, not for diagnosing conditions.
No
The device description clearly states it is a temporary filling material supplied in a jar, which is a physical substance, not software. The performance studies also focus on material properties like compressive strength and setting time.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fabrication of temporary fillings and prosthetics in the mouth (in vivo) to restore carious lesions or structural defects in teeth. This is a direct application to the patient's body.
- Device Description: The device is a temporary filling material applied to teeth. Its curing reaction happens in the oral cavity.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside the body (in vitro) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on bodily specimens.
The device is a dental material used for direct application to the patient's teeth, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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).
Product codes
EBG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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 10993-1:2009, 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 -
Key results:
- Setting Time: Subject Device 27 min, Primary Predicate 55 min
- Compressive Strength: Subject Device 2.2 MPa, Primary Predicate 6.5 MPa
- Acid soluble arsenic contents: Subject Device Not detected, Primary Predicate 0.075
- Shelf Life: Subject Device 3 years, Primary Predicate 2 years
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
§ 872.3770 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
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 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
2
Indications for Use
510(k) Number (if known) K190724
Device Name MD-Temp Plus
Indications for Use (Describe)
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).
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
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
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.
Indication for Use
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).
4
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 |
| Classification | ||
| Name | Crown And Bridge, Temporary, Resin | Crown And Bridge, Temporary, Resin |
| Product Code | EBG | EBG |
| Regulation | ||
| Number | 21 CFR 872.3770 | 21 CFR 872.3770 |
| Indications for | ||
| Use | 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). | For fabrication of temporary fillings | |
| and other temporary prosthetics for use | ||
| until the permanent prosthetic is ready | ||
| for installation. Intended to restore | ||
| carious lesions or structural defects in | ||
| teeth temporarily. Intended for use in | ||
| cavities Classes I, II, III, IV (inlays | ||
| and onlays) and as a restorative | ||
| material for veneers, crowns, and | ||
| bridges. |
5
| Principle of
operation | The main curing reaction of temporary
filling materials is represented by the
hydration reaction of gypsum. | The main curing reaction of temporary
filling materials is represented by the
hydration reaction of gypsum. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Material
Composition | -Vinyl Chloride Vinyl Acetate
Copolymer
-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 |
| Compressive
Strength | 2.2 MPa | 6.5 MPa |
| Acid soluble
arsenic contents | Not detected | 0.075 |
| Shelf Life | 3 years | 2 years |
| Performing
Testing | Tested according to ISO 3107 | Tested according to ISO 3107 |
| Biocompatibility
Testing | 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 -
-
- Material Composition
Compared to the primary predicate, some materials of the subject device have been changed as following:
- Material Composition
| Ingredients from
Primary predicate | Ingredients from
Subject device | Functions in the devices
(Equivalent) |
|---------------------------------------|---------------------------------------------|------------------------------------------|
| Polyvinyl acetate | Vinyl Chloride - Vinyl Acetate
Copolymer | 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.
6
- 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.
-
- 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.
- Indications for Use
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.