APVolution System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 5, 2017 Aesthetic-Press, LLC % Pamela Papineau President Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, Massachusetts 01432 Re: K163228 Trade/Device Name: ApVolution System Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: Class II Product Code: EIH Dated: April 25, 2017 Received: May 2, 2017 Dear Pamela Papineau: 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. 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) 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. Mary S. Runner -A 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}------------------------------------------------ APVolution ᠪြို့နေရွာTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: 19MB498! 8910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K163228 Device Name APVolution System Indications for Use (Describe) The APVolution System is used to fabricate prostheses for missing/damaged teeth. The APVolution pressable ingots are pressed onto metal alloy (APVolution M) or zirconia (APVolution Z) frames by dental technicians to fabricate ceramic restorations. APVolution M and APVolution Z ceramic layering powders and/or pastes are used to layer or build up the pressed ceramic to final tooth morphology. APVolution S ceramic ingots are used to create all-ceramic restorations. AP Stains and Glaze are used during the fabrication process to achieve the correct shade. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: Arial, sans-serif; font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-family: Arial, sans-serif; font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### 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}------------------------------------------------ | Appendix A - 510(k) Summary (revised) | K163228 | |--------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------| | Date: | April 25, 2017 | | Owner's Name: | Aesthetic-Press, LLC | | Address: | 6613 State Road 54<br>New Port Richey, FL 34653 | | Telephone: | 415-692-5372 | | Fax: | 415-723-7075 | | Contact Person: | Pamela Papineau, RAC (US, EU, CAN)<br>Delphi Medical Device Consulting, Inc.<br>5 Whitcomb Avenue<br>Ayer, MA 01432 | | Telephone: | (978) 772-3552 | | Fax: | (978) 796-5460 | | Subject Device: | | | Trade Name: | APVolution System | | Common Name: | Dental Ceramic | | Product Code: | EIH | | FDA Regulation: | 21 CFR 872.6660 - Porcelain Powder for Clinical Use | | Device Classification: | Class II | | Predicate Device: | | | Product Name: | DCceram System | | Common Name: | Dental Ceramic | | Product Code: | EIH | | FDA Regulation: | 21 CFR 872.6660 - Porcelain Powder for Clinical Use | | Device Classification: | Class II | | Premarket Notification: | K141400 | | Indications for Use | | | The APVolution System is used to fabricate prostheses for missing/damaged teeth. The | | The APVolution aged teeth licate pro 18/ da pressable ceramic ingots are pressed onto metal alloy (APVolution M) or zirconia (APVolution Z) frames by dental technicians to fabricate ceramic restorations. APVolution M and APVolution Z ceramic layering powders and/or pastes are used to layer or build up the pressed ceramic to final tooth morphology. APVolution S ceramic ingots are used to create all-ceramic restorations. AP Stains and Glaze are used during the fabrication process to achieve the correct shade. #### Device Description: The APVolution System consists of several silica glass ceramic materials used to create allceramic, ceramic-metal or ceramic-zirconia dental restorations. The APVolution System includes {4}------------------------------------------------ three ceramic ingots for use in the fabrication of all-ceramic (APVolution S), press-to-metal (APVolution M) or press-to-zirconia (APVolution Z) restorations. The system also includes powders and pastes for use in build-up and shaping of the final restoration, as well as shades and glazes for use in achieving acceptable aesthetics. The APVolution System components are listed below in the Substantial Equivalence summary table. ### Substantial Equivalence The Aesthetic-Press APVolution System is substantially equivalent to the Ceramay DCceram System (K141400). Substantial equivalence, which is summarized below, is based on indications for use and device physical and technological characteristics. | | Aesthetic-Press APVolution System<br>(current submission) | Ceramay DCceram System<br>(K141400) | |-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Common/Usual Name | Dental Ceramic | Dental Ceramic | | Device Class | Class II | Class II | | Product Code / Regulation | EIH / 21 CFR 872.6660 | EIH / 21 CFR 872.6660 | | Regulation Name | Porcelain Powder for Clinical Use | Porcelain Powder for Clinical Use | | Prescription Use | Rx Only | Rx Only | | Indications for Use Statement | The APVolution System is used to<br>fabricate prostheses for<br>missing/damaged teeth. The<br>APVolution pressable ceramic ingots<br>are pressed onto metal alloy<br>(APVolution M) or zirconia<br>(APVolution Z) frames by dental<br>technicians to fabricate ceramic<br>restorations. APVolution M and<br>APVolution Z ceramic layering<br>powders and/or pastes are used to<br>layer or build up the pressed ceramic<br>to final tooth morphology.<br>APVolution S ceramic ingots are used<br>to fabricate all-ceramic restorations.<br>AP stains and glaze are used with the<br>APVolution ceramic ingots, powders<br>and/or pastes during the fabrication<br>process to achieve the correct shade. | The DCceram System is used to<br>fabricate prostheses for<br>missing/damaged teeth. The DCceram<br>pressable ceramic ingots are pressed<br>onto metal alloy (APVolution M) or<br>zirconia (APVolution Z) frames by<br>dental technicians to fabricate ceramic<br>restorations. DCceram 12.5 and<br>DCceram 9.2 ceramic layering<br>porcelains and shades are used to layer<br>or build up the pressed ceramic to final<br>tooth morphology and shade on the<br>particular framework (DCceram 9.2<br>zirconia substructures; DCceram 12.5<br>metal substructures). The DCceram<br>conceptPress ceramic ingots are used to<br>fabricate all-ceramic restorations.<br>DCceram conceptArt stains and shades<br>may be used with DCceram<br>conceptPress or DCceram 9.2 ceramics. | | System Components | APVolution M ceramic ingots<br>APVolution Z ceramic ingots<br>APVolution S ceramic ingots<br>APVolution M porcelain powders<br>APVolution Z porcelain powders<br>APVolution M opaque ceramic paste<br>AP stains & glazes | DCceram 9.2 ceramic ingots<br>DCceram 12.5 ceramic ingots<br>conceptPress ceramic ingots<br>DCceram 9.2 liner/layering porcelain<br>DCceram 12.5 liner/layering porcelain<br>DCceram 12.5 opaque ceramic paste<br>conceptArt stains, shades & glazes | | Range of Vita® Tooth Shades | A1 - D4 | A1 - D4 | {5}------------------------------------------------ | | Aesthetic-Press APVolution System<br>(current submission) | Ceramay DCceram System<br>(K141400) | |-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------| | ISO 6872 Type I/II, Class 1a<br>Materials | APVolution M & APVolution<br>ceramic ingots | DCceram 9.2 & DCceram 12.5<br>ceramic ingots | | | APVolution M & APVolution Z<br>porcelain powders | DCceram 9.2 & DCceram 12.5<br>porcelain powders | | | APVolution M opaque ceramic paste<br>AP stains & glazes | DCceram 12.5 opaque ceramic paste<br>conceptArt stains, shades & glazes | | ISO 6872 Type II, Class 4b<br>Materials | APVolution S ceramic ingots | conceptPress ceramic ingots | | | | | | ISO 7405 Biocompatibility | ISO 10993-5 cytotoxicity test: L929<br>cell monolayer proliferation/inhibition<br>during contact with extended (7 day)<br>extraction using DMSO in complete<br>cell culture medium | Meets requirements of ISO 7405<br>Dentistry – Evaluation of<br>Biocompatibility of Medical Devices<br>Used in Dentistry | | ISO 6872 Performance Testing | • Identification of Types & Classes<br>of System Components<br>• Uniformity<br>• Freedom from Extraneous<br>Materials<br>• Mixing & Condensation Properties<br>(Class I Ceramics)<br>• Physical & Chemical Properties<br>• Flexural Strength<br>• Linear Thermal Expansion<br>Coefficient<br>• Glass Transition Temperature<br>• Chemical Solubility<br>• Radioactivity | Meets performance testing<br>requirements of ISO 6872 Dentistry –<br>Dental Ceramics | | Sterile Device | No | No | | Prescription Only | Yes | Yes | | Single Use | Yes | Yes | ## Performance Testing: The APVolution System components have been tested to confirm compliance with ISO 6872 Dentistry - Ceramic Materials. This Abbreviated 510(k) submission includes a Declaration of Conformity to the performance testing methods and acceptance criteria defined in ISO 6872. The specific inspections and tests included in this declaration are listed in the table above. This submission also includes biocompatibility test reports to demonstrate that the APVolution System components meet the biocompatibility requirements described in ISO 7405:2008 Dentistry -Evaluation of biocompatibility of medical devices used in dentistry. Biocompatibility testing consisted of ISO 10993-5 cytotoxicity testing where the proliferation or inhibition of an L929 cell monolayer was evaluated following direct contact with an extended-time (7 day) extract of the system components using DMSO in complete culture medium. The APVolution components met all requirements of the ISO 6872 and ISO 7405 standards. ## Conclusion: The Aesthetic-Press APVolution System has been demonstrated to be substantially equivalent to the predicate device as demonstrated through comparison of the system indications for use, {6}------------------------------------------------ description of system components, biocompatibility testing in accordance with ISO 7405, performance testing in accordance with ISO 6872, and device labeling.