Vericore Gradient Temporary Disc

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May , 11 , 2016 Whip Mix Corporation c/o John P. Waters, Regulatory Compliance Officer 361 Farmington Avenue Louisville, KY 40217 Re: K152443/S002 Trade/Device Name: Vericore® Gradient Temporary Disc Regulation Number: 21 CFR 872.3770 Regulation Name: Crown and Bridge, Temporary, Resin Regulatory Class: Class II Product Code: EGB Dated: April 14, 2016 Received: April 14, 2106 Dear Mr. Waters: 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 801and Part 809); 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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), 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, Susan Runno DDS, mA Erin 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):_K152443 Indications for Use: Vericore ® Gradient Temporary discs is a device made from Polymethylmethacrlate. It is used to mill/fabricate temporary crown or bridge for use in the oral cavity for up to six (6) months while awaiting a permanent restoration. Restorations are designed virtually by a dental professional/technician then manufactured (milled) using CAD technology. Prescription Use______________________________________________________________________________________________________________________________________________________________ × (21 CFR 801 Subpart D) AND/OR Over-The-Counter Use_ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page of of {3}------------------------------------------------ ## 510(K) SUMMARY This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92 ## Date Prepared: May 10, 2016 ## 1. APPLICANT Whip Mix Corporation 361 Farmington Avenue Louisville, KY 40217 PHONE: 502-634-5357 FAX: 502-634-7167 EMAIL: jwaters@whipmix.com ## 2. SUBMITTER and CONTACT John P. Waters Regulatory Compliance Officer & Official Correspondent for Whip Mix Corporation 361 Farmington Avenue Louisville, KY 40217 PHONE: FAX: EMAIL: DATE: ## 3. DEVICE NAME Vericore® Gradient Temporary Disc ## 4. COMMON OR USUAL NAME AND CLASSIFICATION Crown and Bridge, Temporary, Resin Regulation Number: 872.3770 Product Code: EBG Classification: Class II {4}------------------------------------------------ ## 5. PREDICATE DEVICE COMPARISON Whip Mix claims three predicates for our Vericore ® Gradient Temporary Discs. The primary predicate is to Copra-Temp discs manufactured by White Peaks Dental Systems (K131664). The Indications for Use are similar and both devices use Evonik as the supplier of the PMMA raw material supplier. Both devices are similar in regards to flexural strength, chemical solubility, and sorption. Both devices are biocompatible and there are no new risks introduced in regards to substantial equivalence when used in accordance with the Instructions For Use. The secondary and reference predicates are to demonstrate substantial equivalence with the shade materials. Whip Mix K142670 and Jensen Dental K111743 are referenced. Whip Mix claims these predicates for the shading ingredient of red, yellow, and blue. The rest of the information provided for K142670 and K111743 are for informational purposes only. # 6. DEVICE DESCRIPTION Vericore ® Gradient Temporary Discs is a device made from high quality PMMA (polymethylmethacrylate) that is >98%. It is intended for use in the oral cavity as a temporary restoration up to six (6) months while awaiting a permanent restoration. Two (2) pontics are allowed between two (2) abutment teeth. Restorations are designed by the dental technician using CAD technology and uses scans or models from the basis of the restoration to be milled. Vericore ® Gradient Temporary Discs are circular in form and available in a variety of thicknesses for different milling systems and are also available in Vita shades of A1, A2, A3, B1, B2, and Bleach. The device is fabricated in the standard dental laboratory environment. The intended patient population is for anyone needing a temporary crown or bridge while awaiting a permanent restoration. # 7. INDICATIONS FOR USE - Vericore ® Gradient Temporary discs is a device made from ● Polymethylmethacrlate. . It is used to mill/fabricate temporary crown or bridge for use in the oral cavity for up to six (6) months while awaiting a permanent restoration. Restorations are designed virtually by a dental professional/technician then manufactured (milled) using CAD technology. {5}------------------------------------------------ | Item | (NEW) Whip Mix<br>Device | White Peaks<br>(K131664) Copra-<br>Temp Primary<br>Predicate | Whip Mix<br>(K142670)<br>Vericore Zirconia<br>Blanks<br>Secondary<br>Predicate | Jensen Dental<br>(K111743)<br>InSync<br>Ceramic<br>System<br>Reference<br>Predicate | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------| | Class | Class II device | Class II device | Class II device | Class II device | | 510K<br>number | K152433 | K131664 | K142670 | K111743 | | Classificati<br>on Code | EBG | EBG | EIH | EIH | | Shade<br>Ingredient | CAS 1309-37-1<br>CAS 51274-00-1<br>CAS 68187-11-1 | CAS 12035-39-1 | CAS 1309-37-1<br>CAS 51274-00-1 | CAS 68187-11-1 | | Ingredient | PMMA ≥ 98% | PMMA 100% | Zirconia | Porcelain<br>Powder | | Shades | Vita Shades A1, A2,<br>A3, B1 B2, BL | Vita shades A1, A2,<br>A3, B1 | Vita Shades A1, A2,<br>A3, A4, B0, B1, B2 | Ancillary<br>InSync pastes<br>available in all<br>16 Vita shades | | Diameter | 98.5mm | 98.0mm | 98.5mm | Pellets | | Thickness | 12, 16, & 20mm | 15, 16, and 20mm | 10, 12, 14, 16, 20,<br>and 25mm | Pellets | | Milling<br>Technolog<br>y | Milled using CAD<br>technology | Machined using any<br>milling system | Milled using CAD<br>technology | Pressable<br>Silica pellets | | Raw<br>Material<br>Supplier | Evonik ® PMMA<br>beads | Evonik ® PMMA<br>beads | Zirconia Powder<br>from Tosoh | Not specified | | Flexural<br>Strength | 82 MPa | 113 MPa | 533 | Not specified | | Regards to<br>sterility | Sold non-sterile | Sold non-sterile | Sold non-sterile | Sold non-<br>sterile | | Chemical<br>Solubility | -0.2 µg/mm 3 | 0.2 µg/mm 3 | ≤ 18 µg/cm 2 | Not Specified | | Water<br>Sorption | 22 µg/mm 3 | 20.3 µg/mm 3 | NA | Not Specified | | Indication<br>s For Use | Vericore ® Gradient<br>Temporary discs is<br>a device made<br>from<br>Polymethylmethacr<br>late. It is used to<br>mill/fabricate | White Peaks Copra<br>Temp is a device<br>made from high<br>quality 100% PMMA<br>(polymethylmethacr<br>ylate) for the<br>fabrication of | Indications for Use:<br>Vericore zirconia<br>blanks are made<br>from pre-sintered<br>zirconium dioxide<br>intended to be used<br>with many | The pressable<br>ceramic<br>pellets are<br>pressed onto<br>zirconia<br>frames by<br>dental | | | | | | | | or bridge for use in | and bridges and is | manual milling | fabricate full | | | the oral cavity for | intended for use in | machines. Vericore | ceramic | | | up to six (6) | the oral cavity for up | zirconia blanks are | crowns and | | | months while | to six (6) months | biocompatible and | the ceramic | | | awaiting a | while awaiting a | designed to | layering | | | permanent | permanent | fabricate; | porcelain and | | | restoration. | restoration. | | liquids are | | | Restorations are | Restorations are | - Zirconia | used to build | | | designed virtually | designed and | Substructures | up the | | | by a dental | manufactured by a | - Restoration | pressed | | | professional/techni | dental Professional | s (Including | ceramic to | | | cian then | (Technician) using | inlays, | final tooth | | | manufactured | CAD technology | onlays, and | morphology | | | (milled) using CAD | | veneers) | and shade. | | | technology. | | - Crown | The ceramic | | | | | Framework | layering | | | | | in the | porcelain and | | | | | Anterior | liquids are | | | | | and | also used in | | | | | Posterior | building | | | | | regions | ceramic | | | | | - Bridge | crowns and | | | | | Framework | bridges on | | | | | in the | titanium and | | | | | Anterior | titanium alloy | | | | | and | substructures. | | | | | Posterior | Both | | | | | regions | applications | | | | | | are to provide | | | | | | prostheses for | | | | | | missing/dama | | | | | | ged teeth. | | #### 8. SUBSTANTIAL EQUIVALENCE WITH PREDICATE DEVICES {6}------------------------------------------------ # 9. PERFORMANCE TESTING Testing according to ISO 10477 was conducted for Flexural Strength, Water Sorption, and chemical Solubility (same tests as performed on the predicate K131664) and all tests passed the requirements. ## 10. BIOCOMPATIBILITY Whip Mix' Vericore ® Gradient Temporary Discs use the same source for the PMMA as White Peaks and that is Evonik ®. White Peaks performed biocompatibility tests in regards to ISO:10993-3, ISO:10993-5, and ISO:10993-10. Whip Mix listed different shading ingredients than claimed by the predicate from White Peaks. To ensure this did not alter the equivalence claim Whip Mix performed biocompatibility test for the oral mucosa and subject device did not demonstrate any irritation effects on the test subjects. {7}------------------------------------------------ ## 11. PREDICATE DIFFERENCE DISCUSSION Whip Mix claims three predicates to substantial equivalence. Whip Mix Vericore ® Gradient Temporary Discs is substantially equivalent to Whip Mix Vericore Zirconia Blanks (K142670) and Jensen Dental InSync Ceramic Systems (K111743 for the shade ingredients only). The other differences between the new device and the predicates are shown for information only. Whip Mix Vericore ® Gradient Temporary Discs claims substantial equivalence in performance and technological characteristics to White Peaks Copra-Temp K131664. The amount of PMMA claimed, while different, is very similar in the amount of PMMA used. The flexural strength while less than the predicate is similar and passes the minimum requirement which is 50mPA per ISO 10477. There is no correlation between the claimed PMMA percentage and lesser flexural strength. Lastly, the subject device did not demonstrate any irritation effects on the test subjects. ## 12. CONCLUSION Vericore ® Gradient Temporary Discs demonstrate substantial equivalence to Copra-Temp K131664, Whip Mix K142670, and K111743 when used in accordance with the Instructions For Use. Compared to the predicate devices our new device is similar in flexural strength, chemical solubility, sorption tests, shading ingredients, and passed biocompatibility tests.