Meta P&Bond

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is 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. Meta Biomed, Co., Ltd. April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620 Re: K180802 Trade/Device Name: Meta P&Bond Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: March 21, 2018 Received: March 28, 2018 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 August 29, 2018 {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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Mary S. Runner -S For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K180802 Device Name Meta P&Bond Indications for Use (Describe) - · A dental adhesive formulated to adhesively bond to hard tissues of the oral cavity, enamel and dentin - · Dentin-enamel primer/bonding agent for direct composite restorations - · Indirect composite restorative luting system - · Porcelain veneer luting system - · Bonding composite to composite - · Bonding composite to metal/amalgam - · Adhesive amalgam restorations 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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 # Device Information - Trade Name: Meta P&Bond ● - . Classification Name: agent, tooth bonding, resin - Product Code: KLE - Panel: Dental - Regulation Number: 21 CFR 872.3200 - Device Class: Class II - Date prepared: 08/22/2018 ● #### Predicate Devices: - K081913, Meta P&Bond manufactured by Meta Biomed Co., Ltd. #### Device Description Meta P&Bond is a wet bond adhesive system that is activated by visible light curing. This bonding agent is one-step for priming and bonding. It is formulated to adhesively bond to hard surfaces of the oral cavity, namely enamel and dentin, for use with dental cements. It is useful as a primer for use with other methacrylate cements. It is intended to be painted on the interior of a prepared cavity or surface of a tooth to improve retention of a restoration such as a filling or crown. It also is useful as a prime and bonder for porcelain veneer luting, bonding composite, and composite to metal/amalgam. Meta P&Bond is packaged with Microbrush accessories. # Indication for Use - . A dental adhesive formulated to adhesively bond to hard tissues of the oral cavity, enamel and dentin - Dentin-enamel primer/bonding agent for direct composite restorations - Indirect composite restorative luting system - Porcelain veneer luting system - Bonding composite to composite - Bonding composite to metal/amalgam - Adhesive amalgam restorations # 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 {4}------------------------------------------------ # Non-clinical Testing The subject device was tests in accordance to the following standards: - Biocompatibility Tests according to ISO 10993-1:2009, ISO 10993-10:2010, ISO 10993-11:2006. - Performance tests such as visual, capacity, package, film thickness, solubility, sensitivity to ambient light, Depth of cure, Bone strength (Dentin, Enamel) according to ISO 4049:2009. - Shelf Life tests according to ISO4049:2009. # Summary of Technological Characteristics: The subject device and predicate device have same intended use and principle of operation and similar technological characteristics such as capacity, film thickness, sensitivity to ambient light, depth of cure, bond strength and shelf life. The difference between the subject and predicate device is solubility. As the solubility value of the subject device is within the range that ISO 4049:2009, it doesn't affect safety and effectiveness. | | Subject Device | Predicate Device | |---------------------|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | META BIOMED CO., LTD. | META BIOMED CO., LTD. | | Device Name | Meta P&Bond | Meta P&Bond | | 510(k) Number | K180802 | K081913 | | Classification Name | Resin tooth bonding agent | Resin tooth bonding agent | | Product Code | KLE | KLE | | Regulation Number | 21 CFR 872.3200 | 21 CFR 872.3200 | | Intended Use | Identical | ● A dental adhesive formulated<br>to adhesively bond to hard<br>tissues of the oral cavity,<br>enamel and dentin<br>● Dentin-enamel primer/bonding<br>agent for direct composite<br>restorations<br>● Indirect composite restorative<br>luting system<br>● Porcelain veneer luting system<br>● Bonding composite to<br>composite | {5}------------------------------------------------ | | | Bonding composite to metal/amalgam Adhesive amalgam restorations | |---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Principle of operation | Meta P&Bond adhesive system is<br>wet bond adhesive system that is<br>activated by visible light curing.<br>This bonding agent is one step for<br>priming and bonding. | Meta P&Bond adhesive system is wet<br>bond adhesive system that is activated<br>by visible light curing. This bonding<br>agent is one step for priming and<br>bonding. | | Capacity | 1.37% | 2.15% | | Film thickness | $2 \mu m$ | $1 \mu m$ | | Solubility | $1.4 \mu g/mm^2$ | $7.5 \mu g/mm^2$ | | Sensitivity to Ambient<br>Light | Material remained physically<br>homogeneous | Material remained physically<br>homogeneous | | Depth of Cure | 2.9 mm | 3.53 mm | | Bone Strength, Dentine | 17 MPa | 10 MPa | | Bone Strength, Enamel | 31 MPa | 30.76 MPa | | Shelf Life | 2 Years | 2 Years | # Conclusion: Metabiomed Co., Ltd believes that Meta P&Bond is substantially equivalent to the currently legally marketed product based on similar intended use, physical, chemical and mechanical properties. Any differences do not raise different questions of safety and effectiveness than the predicate. These differences therefore, do not render the new device NSE in comparison to the predicate.