ALL-CERAMIC ZIRCONIA BLOCK

{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 representation of a human figure, with three faces overlapping to create a sense of depth and community. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 27, 2014 Rizhao Huge Dental Industry Co., LTD C/O Ms. Helen Nan General Manager Wenzhou Cytech Information Service Co., Ltd. Room 302, No. 21 Building Kaiyu Garden, Xishan South Road Wenzhou, 325000 Zhenjiang Province, CHINA Re: K141162 Trade/Device Name: All-Ceramic Zirconia Block Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: April 15, 2014 Received: June 04, 2014 ## Dear Ms. Nan: 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}------------------------------------------------ Page 2 – Ms. Nan 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}------------------------------------------------ | DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement on last page. | |-------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------| | Indications for Use | | | 510(k) Number (if known) | K141162 | | Device Name | All-Ceramic Zirconia Block | T Indications for Use (Describe) The product is indicated for the production of artificial tech in fixed or removable dentures, or for jacket crowns.facings, and vencers. Type of Use (Select one or both, as applicable) [ 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. . The 2. 2 18 17 : FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) FORM FDA 3881 (1/14) {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a gray graphic with the words "HUGE DENT" in white letters. The graphic is shaped like a curved triangle. The words are stacked on top of each other. RIZHAO HUGE DENTAL INDUSTRY CO.,LTD www.huqedental.cn ## · Intended Use: The product is indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns,facings, and veneers. | 5.3 Comparison of Required Technology Characteristic | | | | |------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------| | | Item | Subject Device | Predicate Device | | | Indication for Use | Indicated for the<br>production of<br>artificial teeth in<br>fixed or<br>removable<br>dentures, or for<br>jacket<br>crowns,facings,<br>and veneers. | Indicated for the<br>production of<br>artificial teeth in<br>fixed or<br>removable<br>dentures, or for<br>jacket<br>crowns,facings,<br>and veneers. | | | Material of Construction | Zirconia Powder | Zirconia Powder | | | Crystal<br>Morphology | Tetragonal | Tetragonal | | | Color | HS&HTIII:<br>White | White | | Physical &<br>Mechanical<br>Properties | Density (pre<br>sintering) | HS:3.10g/cm³<br>HTIII:3.30g/cm³ | 3.10g/cm³ | | | Density (post<br>sintering) | HS&HTIII:<br>6.0-6.1g/cm³ | 6.05g/cm³ | | | Fracture<br>Toughness (pre<br>sintering) | HS: 53.48Mpa<br>HTIII: 54.9Mpa | 55Mpa | | | Fracture<br>Toughness (post<br>sintering) | HS&HTIII:<br>1250Mpa | 1200Mpa | | | Elastic modulus<br>(post sintering) | HS&HTIII:<br>210Gpa | 210Gpa | | | Sintering | HS:1500°C | 1480°C | | HUGE DENT | RIZHAO HUGE DENTAL INDUSTRY CO.,LTD<br>NO.66 of Shanhai Road in Rizhao city, Shandong Province<br>Tel: 0633-2277285 Fax: 0633-2277298 | | | | | temperature | HTIII: 1450°C | | | | Shrinkage (pre<br>sintering) | HS: 0.3% | 20.00% | | | | HTIII: 1.02% | | | | Shrinkage (post<br>sintering) | HS: 20% | 22.00% | | | | HTIII: 18.4% | | | | Porosity | HS & HTIII: 0% | 0% | | Shapes & Sizes | | 2 product<br>families, 2<br>shapes and 8<br>sizes | 7 different<br>product families<br>of shapes and a<br>multitude of<br>different sizes | | | | | | | | | | | | Effectiveness | | Tested<br>According to<br>ISO 6872 | Tested According<br>to ISO 6872 | | | | | | | | | | | | Safety | | Tested<br>According to<br>ISO 10993-3, -5,<br>-10, -11. | Evaluated<br>according to ISO<br>10993-1. | | | | | | | | | | | | | | | | {4}------------------------------------------------ ### Brief Summary: First, the subject device - All-Ceramic Zirconia Block incorporates the same intended use with the predicate device. Secondly, the subject device is composed of the same material - zirconia powder with the predicate device. Thirdly, the two devices are similar in physical&Mechanical properties. Also, both their safety and effectiveness have been verified by appropriate FDA recognized standards. Though they are not identical in shapes and sizes, such minor difference will not influence the core usage of the device, thus will not affecting the devices' substantial equivalence. 6 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the words "HUGE DENT" in a light gray color. The text is slightly angled, with the right side of the text being higher than the left. The background is white, which makes the text stand out. ### 5.4 Discussion of Tests Performed ### · Clinical Tests: Clinical testing was not performed for Aidite Zirconia Dental Ceramics as part of the Pre-market Notification requirements for this submission, as dental ceramics that fall under FDA product code EIH have a long history of safe and effective use in the US. ### · Non-Clinical Tests The subject device was tested to evaluate its safety and effectiveness according to the following standards: - Biocompatibility Test according to AAMI / ANSI / ISO 10993-3:2003/(R)2009, Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity. (Biocompatibility), AAMI / ANSI / ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity. (Biocompatibility), AAMI / ANSI / ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. (Biocompatibility) and AAMI / ANSI / ISO 10993-11:2006/(R)2010, Biological Evaluation Of Medical Devices -- Part 11: Tests For Systemic Toxicity. (Biocompatibility) - Device Effectiveness according to ISO 6872 Third Edition 2008-09-01, Dentistry - Ceramic Materials. (Dental/ENT) #### 5.5 Conclusion: First, the subject device - All-Ceramic Zirconia Block enjoys the same intended use and similar technological characteristics with the predicate device. Besides, the performance safety and effectiveness of the subject device has been verified in accordance with the above FDA recognized standards, thus being considered to be as safe and effective as the predicate device. In a word, it is reasonable for us to conclude that the subject device is substantially equivalent to the predicate device according to the above analysis. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for "HUGE DENT". The logo is set on an orange background that is shaped like a stylized dent. The text "HUGE DENT" is in white and is set in the upper left corner of the orange background. # Section 5 510(k) Summarv (As required by 21 CFR 807.92(a)) # 5.1 Submitter Information - · Company: Rizhao Huge Dental Industry Co.,Ltd - · Address: No.68 Shanhai Road, Rizhao City, 276800, Shandong Province, China - ・ Phone: 086-633-2277285 - · Fax: 086-633-2277298 - · Contact: Steven Song, General Manager - · Date: April 15, 2014. # 5.2 Device Information - · Trade/Device Name: All-Ceramic Zirconia Block - Image /page/6/Picture/16 description: The image shows the word "zirking" in a stylized, italicized font. The word is in black and appears to be a trademark. To the left of the word "zirking" is the word "Trademark:" with a bullet point. · Product Family: HS & HTIII · Classification: Device Class: 2 Review Panel: Dental Name: Powder, Porcelain Regulation Number: 21 CFR 872.6660 Product Code: EIH · Predicate Device: Aidite Zirconia Dental Ceramics submitted by Qinhuangdao Aidite High-Technical Ceramics Co. K Number: K111291 · Device Description: The product is casted by cold isostatic cool pressuring and processed by pre-sintering with zirconia powder as the material. There are two product families within our subject device - HS Series and HTIII Series, which are quite similar in Physical & Mechanical Properties. And the two product families all boast two shapes - the ones without steps and the ones with 2 steps, and eight sizes - 98×10mm for the ones without steps and 98×12mm, 98×14mm, 98×16mm, 98×18mm, 98×20mm, 98×22mm and 98×25mm for the ones with 2 steps. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the words "HUGE DENT" in white text on an orange background. The orange background is in the shape of a rounded, elongated triangle. The text is aligned to the left side of the shape. - Intended Use: The product is indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns,facings, and veneers. | | Item | Subject Device | Predicate Device | | | | | |-------------------------------------------|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------|---------------------------------|---------------------------------------------------------|-------------------------------------------| | | Indication for Use | Indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns,facings, and veneers. | Indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns,facings, and veneers. | | | | | | | Material of Construction | Zirconia Powder | Zirconia Powder | | | | | | | Physical &<br>Mechanical<br>Properties | Crystal Morphology | HS&HTIII:<br>Tetragonal | | | | | | | | Color | HS&HTIII:<br>White | | | | | | | | Density (pre<br>sintering) | HS:3.10g/cm3<br>HTIII:3.30g/cm3 | | | | | | Density (post<br>sintering) | | HS&HTIII:<br>6.0-6.1g/cm3 | 6.05g/cm3 | | | | | | Fracture<br>Toughness (pre<br>sintering) | | HS: 53.48Mpa<br>HTIII: 54.9Mpa | 55Mpa | | | | | | Fracture<br>Toughness (post<br>sintering) | | HS&HTIII:<br>1250Mpa | 1200Mpa | | | | | | Elastic modulus<br>(post sintering) | | HS&HTIII:<br>210Gpa | 210Gpa | | | | | | Sintering | | HS:1500℃ | 1480℃ | | | | | | HUGE DENT | RIZHAO HUGE DENTAL INDUSTRY CO.,LTD<br>www.hugedental.cn | | NO.68 of Shanhai Road in Rizhao city, Shandong Province<br>Tel: 0633-2277285 Fax: 0633-2277298 | | | | | | | temperature | HTIII: 1450°C | | | | | | | | Shrinkage (pre<br>sintering) | HS: 0.3%<br>HTIII: 1.02% | 20.00% | | | | | | | Shrinkage (post<br>sintering) | HS: 20%<br>HTIII: 18.4% | 22.00% | | | | | | | Porosity | HS & HTIII: 0% | 0% | | | | | | | Shapes & Sizes | 2 product<br>families, 2<br>shapes and 8<br>sizes | 7 different<br>product families<br>of shapes and a<br>multitude of<br>different sizes | | | | | | | | | Effectiveness | Tested<br>According to<br>ISO 6872 | Tested According<br>to ISO 6872 | | | | | | | | | Safety | Tested<br>According to<br>ISO 10993-3, -5,<br>-10, -11. | Evaluated<br>according to ISO<br>10993-1. | {8}------------------------------------------------ ## Brief Summary: First, the subject device - All-Ceramic Zirconia Block incorporates the same intended use with the predicate device. Secondly, the subject device is composed of the same material - zirconia powder with the predicate device. Thirdly, the two devices are similar in physical&Mechanical properties. Also, both their safety and effectiveness have been verified by appropriate FDA recognized standards. Though they are not identical in shapes and sizes, such minor difference will not influence the core usage of the device, thus will not affecting the devices' substantial equivalence. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows a logo for a company called "HUGE DENT". The logo is an orange shape that resembles a speech bubble or a rounded rectangle with a curved bottom. The words "HUGE DENT" are written in white, sans-serif font on the orange shape. The word "HUGE" is stacked on top of the word "DENT". ## 5.4 Discussion of Tests Performed ## · Clinical Tests: Clinical testing was not performed for Aidite Zirconia Dental Ceramics as part of the Pre-market Notification requirements for this submission, as dental ceramics that fall under FDA product code EIH have a long history of safe and effective use in the US. ## ・Non-Clinical Tests The subject device was tested to evaluate its safety and effectiveness according to the following standards: - Biocompatibility Test according to AAMI / ANSI / ISO 10993-3:2003/(R)2009, Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity. (Biocompatibility), AAMI / ANSI / ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity. (Biocompatibility), AAMI / ANSI / ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. (Biocompatibility) and AAMI / ANSI / ISO 10993-11:2006/(R)2010, Biological Evaluation Of Medical Devices -- Part 11: Tests For Systemic Toxicity. (Biocompatibility) - Device Effectiveness according to ISO 6872 Third Edition 2008-09-01, Dentistry - Ceramic Materials. (Dental/ENT) # 5.5 Conclusion: First, the subject device - All-Ceramic Zirconia Block enjoys the same intended use and similar technological characteristics with the predicate device. Besides, the performance safety and effectiveness of the subject device has been verified in accordance with the above FDA recognized standards, thus being considered to be as safe and effective as the predicate device. In a word, it is reasonable for us to conclude that the subject device is substantially equivalent to the predicate device according to the above analysis.