(49 days)
Not Found
No
The device description and intended use focus on the material properties and application of a temporary resin, with no mention of AI or ML capabilities.
No
The device is a temporary resin for dental fillings and prosthetics, intended to restore carious lesions or structural defects temporarily, rather than providing a therapeutic effect.
No
The device is described as a temporary resin for fabricating temporary fillings and other temporary prosthetics, which is a restorative function, not a diagnostic one.
No
The device description clearly states it is a "temporary resin" and a "hydraulic temporary restorative," indicating it is a physical material, 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 the fabrication of temporary dental prosthetics and fillings. This is a direct treatment or restoration applied to the patient's teeth.
- Device Description: The device is a temporary resin material used for physical restoration.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, analyze a sample from the 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
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.
Product codes
EBG
Device Description
MD-Temp™ is a temporary resin for formation of temporary fillings, and other temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated. It is a hydraulic temporary restorative. The formula for MD-Temp™ is listed in Attachment I. It is available in white (tooth-like) or pink (gum-like) colors in small jars (e.g. 40 gm.) jars, 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.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K033022, K024282, K002364, K001309, K875133
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.
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JUL 2 1 2006
510 (k) SUMMARY
- Submitter: Mr. T. H. Kim, BioQM Manager, Meta Biomed Co., Ltd., Cheongju City, Chungbuk, Korea. Tel: 82-43-218-1983.
- I. Classification Names and Numbers: Temporary Crown and Bridge Resins were classified by the Dental Panel in CFR 872.3770, Code EBG, Class II,
- Common/Usual Name: Temporary Dental Restorative: Temporary Filling Material. II.
- Proprietary Names: MD-Temp™ III.
XI.
- IV. Establishment Registration Number: Foreign, in process
- Performance Standard: None established under section 514. However, material meets ISO 10993 V. For biocompatibility.
- Device Description: MD-Temp™ is a temporary resin for formation of temporary fillings, and VI. other temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated. It is a hydraulic temporary restorative. The formula for MD-Temp™ is listed in Attachment I. It is available in white (tooth-like) or pink (gum-like) colors in small jars (e.g. 40 gm.) jars, 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.
- Labels and Labeling: Draft labels of MD-Temp™ and instructions for use are VII. provided.
- Indications for Use: For fabrication of temporary fillings and other temporary prosthetics for VIII. 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.
- Substantial Equivalence: MD-Temp™ is substantially equivalent to several temporary resins for tooth IX. restoration currently on the market. These include (among others): "Protemp 3 Garant," K033022; "Acrylic," K024282; "Protemp H," K002364; "Hydro-Cast Bis-Acryl Temporary Crown and Bridge Material," K001309 and "Cavit-W," K875133. Physical properties, compositions, and use of MD-Temp™ are similar to predicate 510(k)s. The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed.
(End of Summary)
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Image /page/1/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a symbol of medicine and health. The text "HUMAN SERVICES - USA" is written around the top of the logo, and the text "PUBLIC HEALTH SERVICE" is written around the bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tae-Hoon Kim BioQM Manager Meta Biomed Company, Ltd. 414-12 Mochoong-Dong Cheongju City, Chunbuck 361-140 REPUBLIC OF KOREA
Re: K061530
Trade/Device Name: MD-Temp™ Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: May 15, 2006 Received: June 05, 2006
Dear Mr. Kim:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determind the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predically equivalent (for the indications for the indications for 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, god manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
JUL 2 1 2006
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. Exist enst it (Special Controls) of class III (PMA), if
found in the Code of Federal Reculetions Titl. 01 Bregulations affecting 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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Page 2 - Mr. Tae-Hoon Kim
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" (21 CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu S. Lin. PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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VIII. Indications for Use: [Separate Page]
KOLIS30 510(k) Number: MA
Device Name: MD-Temp™
Indications for use:
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.
Prescription Use X (Per 21 CFR 801 Subpart D) OR
Over-The-Counter Use (Per 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)
Robert S. Betz DDS for Dr. Susan Runner
inasining
umber. K061530
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