TelioCAD Multi

{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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure in profile, with three overlapping faces. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 12, 2016 Ivoclar Vivadent, Inc. Ms. Donna Marie Hartnett, Esq. Director QA/Regulatory Affairs 175 Pineview Drive Amherst, New York 14228 Re: K153753 Trade/Device Name: TelioCAD Multi Regulation Number: 21 CFR 872.3770 Regulatory Class: Class II Product Code: EBG Dated: March 4, 2016 Received: March 8, 2016 Dear Ms. Donna Marie Hartnett: 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 device-related 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/Resourcesfor You/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 vours. # Erin I. Keith-S 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}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K153753 Device Name TelioCAD Multi Indications for Use (Describe) For manufacturing by a CAD/CAM System: - Provisional anterior and posterior crowns with a maximum wear period of up to 12 months - Provisional anterior and posterior bridges with up to two adjacent pontics for a maximum wear period of up to 12 months - Provisional inlay and onlays Type of Use (Select one or both, as applicable) X 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 TelioCAD Multi Rev April 11, 2016 Image /page/3/Picture/2 description: The image is a logo for Ivoclar Vivadent. The words "Ivoclar Vivadent" are written in a blue sans-serif font, with the "i" in "Ivoclar" being slightly larger than the other letters. Above the words "Ivoclar Vivadent" is an arc of green and blue circles and squares. Below the words "Ivoclar Vivadent" are the words "passion vision innovation" in a smaller, red sans-serif font. | Contact: | Donna Marie Hartnett | |----------------------|----------------------------------------------------------------------------------| | Company: | Ivoclar Vivadent, Inc.<br>175 Pineview Drive, Amherst, NY 14228<br>+716-691-0010 | | Date Prepared: | April 11, 2016 | | Proprietary Name: | Telio® CAD Multi | | Classification Name: | Crown and Bridge, Temporary, Resin (872.3770)<br>(Classification Code EBG) | Device Description: Telio CAD Multi are PMMA discs used for fabrication of long-term temporaries by means of CAD/CAM technology. The PMMA discs have a Long-term (12-month) wear period and durable shade stability with lifelike layered appearance. The device is available in 8 shades (BL2, A1, A2, A3, A3.5, A4, B1 and B2) and 4 thicknesses 12mm, 16mm, 20mm and 25mm. They are the standard 98.5 mm in diameter to permit use with the Wieland Select Milling equipment or other equipment which accepts 98.5 mm discs. The material exhibits high homogeneity due to industrial manufacturing process and temporaries can be easily reproduced using the CAD/CAM Technology. The device is contraindicated for use in permanent restorations and bridge designs involving more than two adjacent pontics. The device should not be used in patients with para-functional habits, ex. Bruxism or patients known to be allergic to the ingredients. #### Indications for Use: For manufacturing by a CAD/CAM system: · Provisional anterior and posterior crowns with a maximum wear period of up to 12 months. • Provisional anterior and posterior bridges with up to two adjacent pontics for a maximum wear period of up to 12 months. • Provisional inlay and onlays ZCAD Temp Esthetic (K132937) by Harvest Dental (Brea.CA) Predicate Device: #### Secondary predicates for reference: 1. Idodentine (Dental Polymer Blank) (K150432) to support 12 month long term wear claim 2. Vipi Block (K102341) for composition and biocompatibility. {4}------------------------------------------------ # 510(K) SUMMARY TelioCAD Multi Rev April 11, 2016 Image /page/4/Picture/2 description: The image shows the logo for Ivoclar Vivadent. The logo is composed of the company name in blue, with the words "passion vision innovation" written in smaller letters below. Above the company name is a semi-circle of green and blue dots, with the green dots on the left and the blue dots on the right. #### Indications for use | Predicate device (K132937) | Telio CAD Multi | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510k clearance, Indications for Use<br>Statement:<br>"The Harvest Dental Polymer Blocks<br>(ZCAD) are PMMA blanks for manufacturing<br>temporary crowns and bridges by a<br>CAD/CAM system." | • Provisional anterior and posterior crowns<br>with a maximum wear period of up to 12<br>months.<br>• Provisional anterior and posterior bridges<br>with up to two adjacent pontics for a<br>maximum wear period of up to 12 months.<br>• Provisional inlay and onlays | | Predicate device (K150432) | Telio CAD Multi | | Time in mouth:<br>Long term temporary (more than 30 days,<br>less than 12 months) | Time in mouth:<br>Long term temporary (more than 30 days,<br>less than 12 months) | #### Principles of operation | Predicate device (K132937) | Telio CAD Multi | |-----------------------------------------|-----------------------------------------| | The blocks are processed by dental | The blocks are processed by dental | | technicians using CAD/CAM technology to | technicians using CAD/CAM technology to | | create temporary restorations. | create temporary restorations. | ### Device Description | Predicate device (K132937) | Telio CAD Multi | |---------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------| | PMMA in the form of polymerized Disc for the<br>fabrication of long-term temporaries by<br>means of the CAD/CAM technology. | PMMA in the form of polymerized discs for<br>the fabrication of long-term temporaries by<br>means of the CAD/CAM technology. | | No accessories | No accessories | | Product available in different thicknesses | Product available in four different<br>thicknesses 12mm, 16mm, 20mm and 25mm | | Available in one translucency: LT | Available in one translucency: LT | | Available in various shades: | Available in BL2, A1, A2, A3, A3.5, A4, B1,<br>B2 | | Compatible with Wieland milling units or any<br>other units accepting 98.5mm discs where<br>open architecture CAM is used in the design,<br>i.e. 3Shape | Compatible with Wieland milling units or any<br>other units accepting 98.5mm discs where<br>open architecture CAM is used in the design,<br>i.e. 3Shape | | The disc delivered unpolished | The subject device is polished on both the<br>top and bottom surfaces to a high gloss.<br>This has no impact on the use, safety or<br>effectiveness of the device. | {5}------------------------------------------------ # 510(K) SUMMARY #### TelioCAD Multi Rev April 11, 2016 Image /page/5/Picture/3 description: The image shows the logo for Ivoclar Vivadent. The logo consists of the company name in a sans-serif font, with "Ivoclar" in a slightly darker shade of blue than "Vivadent." Above the company name is a series of green and blue dots and squares arranged in an arc shape. The dots are on the left side of the arc and the squares are on the right side of the arc. **passion vision innovation** | Predicate device (K132937) | Telio CAD Multi | |-------------------------------------------------|-------------------------------------------------| | The processing steps for the fabrication of | The processing steps for the fabrication of | | the desired restoration are described in the | the desired restoration are described in the | | Instructions for Use. | Instructions for Use. | | Connector dimensions: | Connector dimensions: | | with 1 pontic: at least 12 mm² | with 1 pontic: at least 12 mm² | | with 2 pontics: at least 12 mm² | with 2 pontics: at least 12 mm² | | Polishing, finishing, lining, | Polishing, finishing, lining, | | Seating/cementation: | Seating/cementation: | | Intra-oral cementation using a eugenol-free | Intra-oral cementation to tooth using a | | temporary cement | eugenol-free temporary cement | | Storage conditions: no special conditions | Storage conditions: no special conditions | | Shelf life: no special conditions | Shelf life: no special conditions | | Sterilization: Device is delivered non-sterile | Sterilization: Device is delivered non-sterile | | and no sterilization is recommended for use. | and no sterilization is recommended for use. | #### Materials Tachnology | Predicate device (K132937) | Telio CAD Multi | |----------------------------|-----------------| | PMMA | PMMA | #### Standards | Predicate device (K132937) | Telio CAD Multi | |-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------| | The device was tested to ISO 10477:2004<br>and ISO 20795-1 Dentistry – Base Polymers<br>– Part 1: Denture base Polymers | The device was tested to ISO 10477:2004<br>and ISO 20795-1 Dentistry – Base Polymers<br>– Part 1: Denture base Polymers | Testing Summary: The subject device was not tested for Biocompatibility as no new elements are used in the chemical composition as compared to the predicate device. Biocompatibility evaluation was carried out according to ISO 10993-1 and ISO 7504. No changes have been made which will affect biocompatibility. The device was tested according to ISO 10477:2004 Dentistry - Polymer based crown and bridge materials for Surface finish, Flexural Strength, Bond strength, Water Sorption, Solubility, Shade Consistency and Color stability and the device met all requirements of the standard. The devices was also tested according to ISO 20795-1 :2013 Dentistry - Base Polymers - Part 1: Denture Base Polymers for5 Modulus of Elasticity and Residual monomer and the device met these requirements. Finally, testing according to ISO 179-1:2010 for Charpy toughness, ISO 180:2000 for izod impact strength and ISO 868:2003 for Vickers Hardness (converted from Shore D), was conducted to provide additional insight as to the properties of the materials for its intended use. Conclusion: The above data and analysis demonstrates that Telio®CAD Multi is substantially equivalent to the predicate device.