PEAK

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 22, 2015 Neosil Co., Ltd c/o Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group Usa, Inc. 2651 E Chapman Ave Ste 110 Fullerton, California 92831 Re: K152180 Trade/Device Name: PEAK Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: July 29, 2015 Received: August 4, 2015 Dear Ms. Chung: 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Tina Kiang -S for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K152180 Device Name PEAK Indications for Use (Describe) NS033C is to be used as a light body material for: - Two step putty/wash technique - · Single step putty/wash technique - · Functional peripheries - · Silicon dental impressions - Crown/bridge work - Inlays, Onlays NS017C/NS017T is to be used as a heavy body material for: - Two step putty/wash technique - Single step putty/wash technique - · Functional peripheries - Crown/bridge work - Inlays, Onlays MSP is to be used as a putty body material for: - Two step putty/wash technique - · Single step putty/wash technique - · Functional peripheries - Crown/bridge work - Inlays. Onlays MSBC is to be used as a bite type for: - Making accurate occlusal registrations - · Standards bite registrations in the end bite position. - · Key material for needle point registration. - Production of small model segments MSRC is to be used as a regular body material for: - Two step putty/wash technique - · Single step putty/wash technique - Functional peripheries - Reline impressions - Crown/bridge work - Inlays, Onlays MSCC is to be used as a regular body material for: - Two step putty/wash technique - · Single step putty/wash technique - · Functional peripheries - · Reline impressions - Crown/bridge work - Inlays. Onlays FORM FDA 3881 (1/14) Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) # PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED. # FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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.qov "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." {4}------------------------------------------------ # 510(k) Summary (K152180) This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92. October 21, 2015 Date: ________________________________________________________________________________________________________________________________________________________________________ ## Applicant / Submitter: 1. Neosil Co., Ltd. 63, Gongdanseoro 18beon-gil, Geumjeong-gu, Busan Republic of Korea Tel: +82-51-465-5456 Fax: +82-51-462-6810 ### 2. Submission Correspondent: Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110, Fullerton, CA 92831 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com #### 3. Device: | Proprietary Name: | PEAK | |------------------------------|----------------------------| | Common Name: | Dental Impression Material | | Classification Name: | Material, Impression | | Classification: | Class II, 21 CFR 872.3660 | | Classification Product Code: | ELW | ### 4. Predicate Device: BONASIL A+ by DMP, Limited (K102836) {5}------------------------------------------------ ### Device Description: 5. PEAK is a two component (base paste and catalyst, mixing ratio 1:1) vinyl polysiloxane impression material to be used for impressions, where typically alginates are used. The PEAK offers four different viscosities (light, heavy, putty and regular) in delivery systems of cartridges and jars. The device includes accessories such as a spoon. PEAK offers one light body type: NS033C. PEAK offers two regular body types: MSRC and MSCC with different material compositions and color. The MSCC has clear appearance. PEAK offers two heavy body types: NS017C/NS017T and MSBC with different material compositions and color. MSBC is a bite type particularly. #### 6. Intended Use: NS033C is to be used as a light body material for: - Two step putty/wash technique . - Single step putty/wash technique - Functional peripheries . - Silicon dental impressions - Crown/bridge work . - Inlays, Onlays NS017C/NS017T is to be used as a heavy body material for: - Two step putty/wash technique . - Single step putty/wash technique . - · Functional peripheries - Crown/bridge work - · Inlays, Onlays MSP is to be used as a putty body material for: - Two step putty/wash technique . - Single step putty/wash technique - Functional peripheries . - Crown/bridge work - Inlays, Onlays MSBC is to be used as a bite type for: - · Making accurate occlusal registrations - · Standards bite registrations in the end bite position. - Key material for needle point registration. . - Production of small model segments MSRC is to be used as a regular body material for: - Two step putty/wash technique . - Single step putty/wash technique . - · Functional peripheries - · Reline impressions - Crown/bridge work {6}------------------------------------------------ - Inlays, Onlays . MSCC is to be used as a regular body material for: - Two step putty/wash technique - . Single step putty/wash technique - · Functional peripheries - · Reline impressions - Crown/bridge work - Inlays, Onlays ## Performance Data(Non-Clinical): 7. The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices. - . ISO 4823 - Consistency Test, Mixing Time Test, Working Time Test, Detail Reproduction Test, Test for Compatibility with Gypsum, Linear Dimensional Change Test, Elastic Recovery Test, and Strain-in-Compression Test - ISO 10993-5 Cytotoxicity Test . - ISO 10993-10 Skin Sensitization Test, Oral Mucous Irritation Test . - . ISO 10993-11 - Acute Systemic Toxicity Test - . Other bench testing - Shelf life, Visual Inspection, Weight and Component Color Check #### 8. Substantial Equivalence The PEAK is substantially equivalent to the predicate device described herein with respect to intended use, device design, accessory components, base material and delivery method. Also the curing mechanism of the subject device and the predicate devices is substantially equivalent in principle. This supports that the compatibility of the subject device are substantially equivalent to the predicate devices. The difference might be the compositions of some materials; however, the biocompatibility and the results of performance testing performed according to ISO 4823 show that this difference does not raise issues in safety and effectiveness. | | Subject Device | Predicate Device | |---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(K) Number | N / A | K102836 | | Trade Name | PEAK | BONASIL A+ | | Manufacturer | Neosil Co., Ltd | DMP, Limited | | Product Code | ELW | ELW | | Intended Use | NS033C is to be used as a light body material for:<br>- Two step putty/wash technique | Bonasil A+ Light (light normal set, light fast set) is to be used as a light body material for :<br>- Two step putty/wash technique | | | Single step putty/wash technique Functional peripheries Silicon dental impressions Crown/bridge work Inlays, Onlays NS017C/NS017T is to be used as a heavy body material for: Two step putty/wash technique Single step putty/wash technique Functional peripheries Crown/bridge work Inlays, Onlays MSP is to be used as a putty body material for: Two step putty/wash technique Single step putty/wash technique Functional peripheries Crown/bridge work Inlays, Onlays MSBC is to be used as a bite type for: Making accurate occlusal registrations Standards bite registrations in the end bite position. Key material for needle point registration. Production of small model segments MSRC is to be used as a regular body material for: Two step putty/wash technique Single step putty/wash technique Functional peripheries Reline impressions Crown/bridge work Inlays, Onlays MSCC is to be used as a regular body material for: Two step putty/wash technique Single step putty/wash technique Functional peripheries Reline impressions Crown/bridge work Inlays, Onlays | Single step putty/wash technique Functional peripheries Reline impressions Crown/bridge work Inlays, Onlays Bonasil A+ Heavy (heavy normal set, heavy fast set) is to be used as a heavy body material for : Two step putty/wash technique Single step putty/wash technique Functional peripheries Crown/bridge work Inlays, Onlays Bonasil A+ Putty (putty normal set, putty fast set, putty soft, putty extra hard, lab putty) is to be used as a preliminary material for : Two step putty/wash technique Single step putty/wash technique Functional peripheries Crown/bridge work Inlays, Onlays Bonasil A+ Bonabite (bonabite fast set) is to be used as a light body material for: Making accurate occlusal registrations Standards bite registrations in the end bite position. Key material for needle point registration. Production of small model segments | | Raw Material | Vinyl polysiloxane | Vinyl polysiloxane | | Human Factor | Ready to use dispensing system | Ready to use dispensing system | | Biocompatibility | Biocompatible conforming to ISO 10993-1 | Biocompatible conforming to ISO 10993-1 | | | Meets ISO 4823 specifications | Meets ISO 4823 specifications | | Physical Properties | 1) NS033C<br>- Working time : more than 40sec<br>- Elastic recovery rate : more than 96.5%<br>- Linear Dimensional change : less than 1.5%<br>- Classification according to the standards (ISO 4823) : Type 3 | 1) Bonasil A+ Light<br>- Working time : about120sec<br>- Elastic recovery rate : more than 96.5%<br>- Linear Dimensional change : less than 1.5%<br>- Classification according to the standards (ISO 4823) : Type 3 | | | 2) NS017C/NS017T<br>- Working time : more than 40sec<br>- Elastic recovery rate : more than 96.5%<br>- Linear Dimensional change : less than 1.5%<br>- Classification according to the standards (ISO 4823) : Type 1 | 2) Bonasil A+ Heavy<br>- Working time : about 120sec<br>- Elastic recovery rate : more than 96.5%<br>- Linear Dimensional change : less than 1.5%<br>- Classification according to the standards (ISO 4823) : Type 1 | | | 3) MSP<br>- Elastic recovery rate : more than 96.5%<br>- Linear Dimensional change : less than 1.5%<br>- Classification according to the standards (ISO 4823) : Type 0 | 3) Bonasil A+ Putty<br>- Elastic recovery rate : more than 96.5%<br>- Linear Dimensional change : less than 1.5%<br>- Classification according to the standards (ISO 4823) : Type 0 | | | 4) MSBC<br>- Working time : more than 30sec<br>- Linear Dimensional change : less than 1.5%<br>- Classification according to the standards (ISO 4823) : Type 1 | 4) Bonasil A+Bonabite<br>- Working time : about 30sec<br>- Linear Dimensional change : less than 1.5%<br>- Classification according to the standards (ISO 4823) : Type 2<br>- Hardness : more than 20HD | | | 5)MSRC<br>- Mixing time : more than 30sec<br>- Elastic recovery rate : more than 96.5%<br>- Linear Dimensional change : less than 1.5%<br>- Classification according to the standards (ISO 4823) : Type 2 | | | | 6)MSCC<br>- Mixing time : more than 30sec<br>- Elastic recovery rate : more than 96.5%<br>- Linear Dimensional change : less than 1.5%<br>- Classification according to the standards (ISO 4823) : Type 2 | | | Mixing ratio | 1:1 | 1:1 | | Sterility | Non-sterile | Non-sterile | {7}------------------------------------------------ {8}------------------------------------------------ # 9. Conclusion: Based on the testing results, Neosil Co., Ltd. concludes that the PEAK is substantially equivalent to the predicate devices.