MD-TEMP

K061530 · Meta Biomed Co., Ltd. · EBG · Jul 21, 2006 · Dental

Device Facts

• Record ID: K061530
• Device Name: MD-TEMP
• Applicant: Meta Biomed Co., Ltd.
• Product Code: EBG · Dental
• Decision Date: Jul 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

MD-Temp™ is a hydraulic temporary resin restorative material; used by dentists to form temporary fillings, crowns, bridges, and veneers. Material applied to cavities or structural defects; provides temporary protection until permanent restoration fabrication. Available in white or pink colors; supplied in jars. Operates as a temporary filling material; physical properties and composition similar to existing market resins. Benefits patient by maintaining tooth function and structure during interim period before permanent prosthetic placement.

Clinical Evidence

No clinical data provided. Biocompatibility testing performed per ISO 10993 standards.

Technological Characteristics

Hydraulic temporary resin restorative material. Biocompatibility meets ISO 10993. Available in white or pink. Non-electronic, non-software device.

Indications for Use

Indicated for patients requiring temporary restoration of carious lesions or structural tooth defects. Used for temporary fillings, inlays, onlays (Classes I-IV), veneers, crowns, and bridges until permanent prosthetic installation.

Regulatory Classification

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.

Predicate Devices

• Protemp 3 Garant (K033022)
• Acrylic (K024282)
• Protemp H (K002364)
• Hydro-Cast Bis-Acryl Temporary Crown and Bridge Material (K001309)
• Cavit-W (K875133)

Submission Summary (Full Text)

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K061530

JUL 2 1 2006

## 510 (k) SUMMARY

- Submitter: Mr. T. H. Kim, BioQM Manager, Meta Biomed Co., Ltd., Cheongju City, Chungbuk, Korea. Tel: [phone].
- 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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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 [phone]. 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 [phone] or [phone] 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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