CharmFlex

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle with three human profiles incorporated into its design. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 13,2016 Dentkist, Inc. c/o Mr. Peter Chung President Plus Global 300 Atwood Street Pittsburgh, Pennsylvania 15213 Re: K152766 Trade/Device Name: CharmFlex® Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: February 1, 2016 Received: February 5, 2016 Dear Mr. Peter Chung: This letter corrects our substantially equivalent letter of March 8, 2016. 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); 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 ), 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" (21CFR 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, Susan Runke DDS, MA 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) K152766 Device Name CharmFlex® Indications for Use (Describe) - Impression material in a dual phase impression technique - Precise duplication of models - Capturing multiple unit impressions Type of Use (Select one or both, as applicable) الص 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.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." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ # 510(k) Summary [as required by 807.92(c)] # 1. Applicant - 1) Company : Dentkist, Inc - 2) Address : (Dangjeong-dong) 3, Nongshim-ro, Gunpo-si, Gyeonggi-do, Korea - 3) Tel : 82-31-458-2822 - 4) Fax : 82-31-458-1312 - 5) Prepared date : March 7, 2016 - 5) Contact person : Peter Chung, 412-687-3976 - 6) Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA - 7) Submission date : Sep. 18, 2015 # 2. Device Information - 1) Trade name : CharmFlex® - 2) Common name : Dental Impression Materials - 3) Classification name : Impression Material - 4) Product code : ELW - 5) Regulation number : 872.3660 - 6) Class of device : Class II - 7) Panel : Dental - 8) Model codes : 13 model codes including CharmFlex® Putty - -CharmFlex® Putty - CharmFlex® Putty Green । - CharmFlex® Putty Soft - - CharmFlex® Heavy cartridge type - - CharmFlex® Heavy tube type - - CharmFlex® Regular - - -CharmFlex® Denture - -CharmFlex® Light LV - -CharmFlex® Light XLV - CharmFlex® Light Premium - - CharmFlex® Bite - - CharmFlex® Bite Clear - - CharmFlex® Bite Fast - ## 3. The legally marketed device to which we are claiming equivalence Primary Predicate: K103164 VonflexTM Heavy/VonflexTM Light Reference Predicates: K091267 Vonflex™ Putty K140966 Vonflex™ Bite Manufacutred by VERICOM CO.,LTD. ## 4. Device description CharmFlex is impression material. It has 5 types: Putty, Regular, Light, Heavy, Bite. - 1) CharmFlex®Putty/ CharmFlex®Putty Green/ CharmFlex®Putty Soft CharmFlex®Putty consists of various Putty-bodies type and dental addition silicone impression material made by polymerization as a mixture of Base and Catalyst. In dental treatment, an impression material used to record oral tissue anatomy. CharmFlex®Putty has viscosity of putty consistency classification according to type 0 {4}------------------------------------------------ ISO 4823 classification. Packaging consists of two putty systems which are supplied by in two jars, the one is base and another is catalyst. This product is used for two step impression and the material for the first impression is for recording oral tissue anatomy. Base and catalyst of impression are packed separatelv - 2) CharmFlex®Heavy cartridge type/ CharmFlex®Heavy tube type CharmFlex® Heavy series are hydrophilic vinyl polysiloxane impression materials type of Heavybodies. It is used for the one-step impressions teeth or individual tooth in the mouth. CharmFlex®Heavy as the additional polymerization silicone type is rubber impression materials that registers oral tissue anatomy. It is used with Light-body for impression taking. Packages are cartridge type which is supplied by from of two syringes. This product is used for the first or second impression taking of whole teeth or individual tooth in mouth before the final impression taking. It is silicone based dental rubber impression materials. - 3) CharmFlex®Regular/ CharmFlex®Denture/ CharmFlex®Light LV/ CharmFlex®Light XLV/ CharmFlex®Light Premium CharmFlex® Light series are hydrophilic vinyl polysiloxane impression material type of LightLV, Regular and LightXLV. It is used for the one-step or two-step impression taking of teeth or individual tooth in the mouth. CharmFlex® Light XLV/Regular series as the additional polymerization silicone type are rubber impression materials that records oral tissue anatomy. Packages are cartridge type which is supplied by from of two syringes. This product is used for the first or second impression taking of teeth or individual tooth in mouth before the final impression taking. It is silicone based dental rubber impression materials. - 4) CharmFlex®Bite/ CharmFlex®Bite Clear/ CharmFlex®Bite Fast CharmFlex Bite series are bite registration impression material to measure of the occlusal surface. impression of the teeth for a three-dimension position of the mandible in relation to the maxilla. It has a short polymerization time and a high final hardness. Making it suitable for bite registration. ## 5. Indications for Use : - Impression material in a dual phase impression technique - Precise duplication of models - Capturing multiple unit impressions {5}------------------------------------------------ ## 6. Performance data: Bench test | Test items | Standards | |-------------------------------|--------------------------------------------------------| | Appearance test | | | Weight test | | | Component test | | | Working time test | | | Minimum strength test | | | Hardness test | ISO 4823 Dentistry-Elastomeric impression<br>materials | | Linear dimensional chage test | | | Consistency | | | Working time | | | Detail reproduction | | | Compatibility with gypsum | | | Elastic recovery | | | Strain-in-compression | | Biocompatibility Testing - Cytotoxicity according to ISO 10993-5 . - Systemic Toxicity according to ISO 10993-● - Oral Mucosa Irrifation Testing according to . 10993-10 - Shelf-Life Validation Accelerated shelf-iffe testing was conducted according to ASTM 1980 to confirm the shelf-life of the subject device. #### FDA Guidance Document Conformance to the recommendation in the FDA Guidance Document for Dental Impression Materials. #### 7. Predicate device comparison table - 1) CharmFlex Heavy / CharmFlex Light LV / CharmFlex Light XLV / CharmFlex Reqular | | Subject Device | Predicate Device | |---------------------|-------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company | Dentkist, Inc. | VERICOM Co., Ltd. | | Device Name | CharmFlex Heavy / CharmFlex Regular /<br>CharmFlex Denture / CharmFlex Light LV /<br>CharmFlex Light XLV / CharmFlex Light<br>Premium | VonflexTM Heavy / VonflexTM Light /<br>VonflexTM Medium | | 510(k) # | N/A | K103164 | | Classification | Material, Impression | Material, Impression | | Product Code | ELW | ELW | | Regulation | 21 CER 872.3660 | 21 CER 872.3660 | | Indications for Use | - Impression material in a dual phase impression<br>technique<br>- Precise duplication of models<br>- Capturing multiple unit impressions | - Impression material in a dual phase impression<br>technique<br>- Precise duplication of models<br>- Capturing multiple unit impressions<br>- All impression techniques where the operator<br>needs a heavy or low viscosity material | {6}------------------------------------------------ | Method of<br>manipulation | | 1. Cartridge-Light, Medium, Heavy | |---------------------------|------------------------------------------------------------------------------------|--------------------------------------------------------------| | | 1. CharmFlex Heavy | Place the cartridge of Vonflex S into a impression | | | 1) Tube type : Squeeze equal volume of Base | gun. Squeeze the cartridge several times to | | | and | extrude the material. Dispense a small amount of | | | Catalyst (1:1) and mix quickly with a tool for | impression material before installing a mixing tip to | | | 1'30" and load Heavy-body on the tray. | ensure even flow from each side of the cartridge. | | | Cartridge type : Apply Heavy-body on the tray. | 2. Tube-Heavy | | | 2) Inject Light-body on tray and directly onto the | Squeeze the same amount of Vonflex S, Catalyst | | | teeth. ( Intra oral tip is used to inject around the | and Base on a mixing pad. Mixing ratio is 1 volume | | | teeth.) | Base: 1 volume Catalyst for Vonflex S. Mix them | | | 3) Set the tray in the mouth, keep the material until | quickly within 30 seconds with spatula until two | | | it is perfectly set in mouth. | different colors are mixed into the same color<br>perfectly. | | | 4) After impression material is perfectly set, store it<br>in room for 30 minutes. | 3. Prior to taking the impression, remove any | | | 2. CharmFlex Regular / CharmFlex Denture / | residue of pollutants in the oral by rinsing and dry | | | CharmFlex Light LV / CharmFlex Light XLV / | completely. | | | CharmFlex Light Premium | 4. Put Medium or Heavy into the tray, and then | | | 1) Apply the materials onto the tray of putty (2- | load Light body with mixing tip on it. | | | step) / Heavy Body (1-step) depending on | 5. Load Light body with a mixing tip on the | | | techniques being used. | preparations inside of a mouth. And seat the | | | 2) Set the tray in the mouth, keep the material until | loaded tray on the preparations to get a final | | | it is perfectly set in mouth. | impression | | | 3) After impression material is perfectly set, store it | 6. after setting the impression, remove the tray | | | in room for 30 minutes. | from the mouth. And rinse it with water or disinfect | | | | it by using any ADA accepted liquid disinfectant. | | | - Vinyl Siloxane | - Vinyl Siloxane | | Chemical composition | - Hydrogen Siloxane | - Hydrogen Siloxane | | | - Silicon dioxide | - Fumed Silica | {7}------------------------------------------------ | | - Calcium silicate<br>- Mineral Oil<br>- Pigments | - Organo Platinum Complex<br>- Polyethylene glycol dodecyl ether<br>- Pigments | |--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------| | Flow properties | Low viscosity<br>Heavy(high viscosity) | Light(Low viscosity)<br>Medium(medium viscosity)<br>Heavy(high viscosity) | | Viscosity | 48mm<br>Heavy(34.25mm) | Light(42mm), Medium(36mm), Heavy(33mm) | | Wettability | High, Heavy(Low) | Light(high), Regular(medium), Heavy(Low) | | Working time | 1.CharmFlex Heavy cartridge type: 1'30"<br>2.CharmFlex Heavy tube type: 2'<br>3.CharmFlex Regular/<br>CharmFlex Denture/CharmFlex Light LV/<br>CharmFlex Light XLV/CharmFlex Light<br>Premium: 2'~2'30" | Light: 1'30"~2'30"<br>Medium, Heavy: 1'30"~2'15" | | Setting time | 2'~4' | 4' | | Mechanical strength | 55~65<br>Heavy(62±2) | Light(50±2), Medium(55±2), Heavy(64±2) | | Working humidity | 50±10% | 50±10% | | Dimension accuracy | 20 μm | 22 μm | | Strain in compression | 4.0~5.0% | 4.0~5.0% | | Consistency | 48mm<br>Heavy(34.25mm) | Light(42mm), Medium(36mm), Heavy(33mm) | | Safety | safe | safe | | Compatibility with the<br>die and cast materials | 20 μm | 22 μm | | Keeping qualities | cool and dry place (18~24 °C/64~75 °F) | At a cool place(2~24 °C) | | Curve of the shrinkage | No data | No data | | Use | Dentist, Dental specialist | Dentist, Dental specialist | # 2) CharmFlex Putty / CharmFlex Putty Green / CharmFlex Putty Soft | | Subject Device | Predicate Device | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company | Dentkist, Inc. | VERICOM Co., Ltd. | | Device Name | CharmFlex Putty / CharmFlex Putty<br>Green / CharmFlex Putty Soft | VonflexSTM Putty | | 510(k) | N/A | K091267 | | Classification | Material, Impression | Material, Impression | | Product Code | ELW | ELW | | Regulation | 21 CER 872.3660 | 21 CER 872.3660 | | Indications for Use | - Impression material in a dual phase<br>impression technique<br>- Precise duplication of models<br>- Capturing multiple unit impressions | - Impression material in a dual phase impression<br>technique<br>- Precise duplication of models<br>- Capturing multiple unit impressions<br>- All impression techniques where the operator needs a<br>heavy or low viscosity material | | Method of<br>manipulation | 1. Take out the same amount of Base and<br>Catalyst. (1:1 vol.)<br>2. Knead them properly with hands until a<br>mixed color is attained. Wear disposable vinyl<br>gloves to prevent your hands from incurring an<br>allergic reaction.<br>3. Apply the mixed material to the tray and set<br>into the mouth.<br>4. After the material is perfectly set, remove<br>from the mouth.<br>5. Set the tray with Light-body on the<br>completed Putty-body into the mouth.<br>6. After the material is perfectly set, store it in<br>room for 30 minutes. | 1. Take the same volume of Base and Catalyst with a<br>measuring scoop. Knead them quickly within 30 seconds<br>with clean and dry hands until two different colors are<br>mixed into the same color perfectly.<br>2. Place Vonflex S putty in to a selected tray and remove<br>the excess of it on the surface.<br>3. On setting the Vonflex S putty completely, remove the<br>tray from the mouth with moving slightly back and forth.<br>4. Load Medium or Light body with a mixing tip on the<br>preparations inside of a mouth<br>5. Put Medium or Light body on pre-impression and seat<br>the loaded tray on the preparations to get a final<br>impression.<br>6. After setting the impression, remove the tray from the<br>mouth. And rinse it with water or disinfect it by using any<br>ADA accepted liquid disinfectant. | | Chemical composition | -Polyvinyl siloxane<br>-Silica | -Polyvinyl siloxane<br>-Silica | {8}------------------------------------------------ | Flow properties | High viscosity | High viscosity | |--------------------------------------------------|----------------------------------------|----------------------------| | Viscosity | 25.83mm | 26.32mm | | Wettability | Low | Low | | Working time | 1'~1' 30" (26 °C) | 1.30min~2min (23 °C) | | Setting time | 2.22'~4' | 2.30min~4min | | Mechanical strength | 65~85 | 62~75 | | Working humidity | 50%±10 | 50%±10 | | Dimension accuracy | 30 μm | 28 μm | | Strain in compression | 3.0~4.0% | 3.0~4.0% | | Consistency | 25.83mm | 26.32mm | | Safety | safe | safe | | Compatibility with the<br>die and cast materials | 30 μm | 28 μm | | Keeping qualities | cool and dry place (18~24 °C/64~75 °F) | At a cool place(2~24 °C) | | Curve of the<br>shrinkage | No data | No data | | Use | Dentist, Dental specialist | Dentist, Dental specialist | # 3) CharmFlex Bite / CharmFlex Bite Clear / CharmFlex Bite Fast | | Subject Device | Predicate Device | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company | Dentkist, Inc. | VERICOM Co., Ltd. | | Device Name | CharmFlex Bite / CharmFlex Bite Clear / | Vonflex STM Bite | | | CharmFlex Bite Fast | | | 510(k) | N/A | K091267 | | Classification | Material, Impression | Material, Impression | | Product Code | ELW | ELW | | Regulation | 21 CER 872.3660 | 21 CER 872.3660 | | Indications for Use | - Impression material in a dual phase<br>impression technique<br>- Precise duplication of models<br>- Capturing multiple unit impressions | - Impression material in a dual phase impression<br>technique<br>- Precise duplication of models<br>- Capturing multiple unit impressions<br>- All impression techniques where the operator needs a<br>heavy or low viscosity material | | Method of<br>manipulation | 1. Check the expiration date and avoid<br>package contamination.<br>2. Follow the instructions for use before using.<br>3. Place a disposable mixing tip on cartridge,<br>and place the cartridge on exclusive mixing<br>gun.<br>4. Check to be made to mix well during<br>extrusion through the tips.<br>5. Apply bite registration material directly onto<br>the occlusal surfaces.<br>6. Set this material to intraoral until the impression<br>material completely polymerized.<br>7. Remove the set bite registration from<br>intraoral.<br>8. Make a master cast with a instrument such<br>as a dental knife. | 1. Prior to taking Vonflex S Bite, completely remove any<br>residue of pollutants in the oral by rinsing and drying.<br>2. Place the cartridge of Vonflex S Bite into the<br>impression gun.<br>3. Dispense a small amount of impression material<br>before installing a mixing tip to ensure even flow from<br>each side of the cartridge<br>4. Push firmly to attach the mixing tip in the cartridge.<br>Then, rotate the colored collar of the mixing tip 1/4 turns<br>clockwise to the end of the cartridge.<br>5. Squeeze the handle several times to extrude the<br>material onto occlusal of teeth. Guide patient into centric<br>occlusion to register bite.<br>6. After the material set, remove it from mouth. If you<br>have extra material after removing the trim undercut.<br>7. Make sure the bite registration and ready model. | | Chemical composition | -Polyvinyl siloxane<br>-Silica | -Polyvinyl siloxane<br>-Silica | | Flow properties | High viscosity | High viscosity | | Viscosity | 32mm | 30mm | | Wettability | Low | Low | | Working time | 20~35sec(23℃) | 30~45sec(23℃) | | Setting time | 30~60sec | 30~90sec | | Mechanical strength | 89±2 | 88±2 | {9}------------------------------------------------ | Working humidity | 50%±10 | 50%±10 | |--------------------------------------------------|----------------------------------------|----------------------------| | Dimension accuracy | 1.5 μm | 2 μm | | Strain in compression | 1.5~2.5% | 1.5~2.5% | | Consistency | 32mm | 30mm | | Safety | safe | safe | | Compatibility with the<br>die and cast materials | 1.5 μm | 2 μm | | Keeping qualities | cool and dry place (18~24 °C/64~75 °F) | At a cool place(2~24 °C) | | Curve of the<br>shrinkage | brittle feature | brittle feature | | Use | Dentist, Dental specialist | Dentist, Dental specialist | The subject device and primary predicate have slightly different Indications for Use language. However, the difference in language does not change the intended use or substan ### 9. Conclusion: Comparison results demonstrate that the specifications and performance of the device are same as the leqally marketed predicate device. Therefore, it is concluded that CharmFlex® is substantially equivalent to the legally marketed predicate device.