BV Dental Implant System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 18, 2020 Bio Concept Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai 200120 CHINA Re: K192274 Trade/Device Name: BV Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: April 27, 2020 Received: May 19, 2020 Dear Diana Hong: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K192274 Device Name BV Dental Implant System # Indications for Use (Describe) The BV Dental Implant System is indicated for use in partially or fuilly edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. 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) | # 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}------------------------------------------------ # Exhibit # 2 510(k) Summary This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92. The assigned 510(k) Number: K192274 - 1. Date of Preparation: 06/17/2020 - 2. Sponsor Identification # BIO CONCEPT CO., LTD Unit C, No.26, Huashan Middle Road, Xinbei Zone, Changzhou, Jiangsu 213022, China Establishment Registration Number: 3012465917 Contact Person: Xiaodong Dai Position: General Manager Tel: +86-519-85172266 Fax: +86-519-85172299 Email: daixiaodong@bioconcept.cn - 3. Designated Submission Correspondent Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person) # Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net {4}------------------------------------------------ #### Identification of Proposed Device 4. Trade Name: BV Dental Implant System Common Name: Endosseous dental implant Regulatory Information Classification Name: Endosseous implant Classification: II Product Code: DZE Secondary Product Code: NHA Regulation Number: 21 CFR 872.3640 Review Panel: Dental Indications for Use The BV Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-units restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. ## Device Description The proposed devices, dental implant system consists of dental implants, abutments and healing cap, it is used in one or two-stage dental implant placement and restoration. The dental implants are available in Mini and Regular two types. The implant is made from titanium and the surface of the implants are treated with Sandblasting and Acid etching. The implants are provided in lengths from 7.0-15.0 and in diameter from 3.7 to 6.8. The abutments in this submission include transfer abutment, temporary abutment, multi abutment, multi angled abutment, equator abutment and Esthetic-low Temporary Cylinder. The abutment is also available in mini and regular two types to match with the corresponding implant. The abutment is made from titanium alloy. The healing cap in this submission include cover screw, healing abutment and equator healing abutment. {5}------------------------------------------------ - ડ. Identification of Predicate Device 510(k) Number: K121995 Product Name: TS Fixture System Manufacturer: Osstem Implant Co., Ltd. #### 6. Identification of Reference Devices Reference Device 1 510(k) Number: K182091 Device Name: OSSTEM Abutment System Manufacturer: OSSTEM Implant Co., Ltd. Reference Device 2 510(k) Number: K150388 Device Name: Dental Implant System Manufacturer: Bio Concept Co., Ltd #### 7. Non-Clinical Test Conclusion Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test provided in this submission include # Biocompatibility test The patient-contact materials of proposed implant are identical to the device cleared in K150388 which is also manufactured by the applicant. Therefore, the biocompatibility test for the implant will leverage on the test performed on the device K150388 and additional test is not performed. The proposed abutment was evaluated for cytotoxicity per ISO 10993-5 and the test result show that there was no cytotoxicity. # Surface test The modified surface for the proposed device is same as the device cleared in K150388 which is also manufactured by the applicant. Therefore, the surface test will leverage on the test report performed on the device K150388 and additional test is not performed. ### Bacteria Endotoxin Test Bacteria endotoxin test was conducted on the device per USP 85. The test result show that the endotoxin is less than 20EU per device. {6}------------------------------------------------ # Mechanical test Mechanical strength test was performed on the proposed device and predicate device. The result show that there was no significant difference between them. # Sterilization The dental implants were provided in sterile and subject to radiation sterilization. The sterilization process were validated per ISO 11137-1 and ISO 11137-2. The abutments and healing cap were provided in non-sterile and subject to steam sterilization process by end user. The sterilization process were validated per ISO 17665-1 and ISO 17665-2. The test results demonstrated that the proposed device complies with the following standards and guidance - > ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro Cytotoxicity - > ISO 14801:2016 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants - > USP <85> Bacterial Endotoxin Test - > ASTM F136-13, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications - > ASTM F67-13 (Reapproved 2017), Standard Specification for Unalloyed Titanium for Surgical Implant Applications - > ISO 11137-1 Sterilization of health care products-Radiation-Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - > ISO 11137-2 Sterilization of health care products-Radiation-Part 2: Establishing the sterilization dose - > ISO 17665-1 Sterilization of health care products-Moist heat-Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices - > ISO 17665-2 Sterilization of health care products-Moist heat-Part 2: Guidance on the application of ISO 17665-1 - A Use of International Standard ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - A Root-form Endosseous Dental Implants and Endosseous Dental Abutments - > Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - > Submission and Review of Sterility Information in Premarket Notification (510(k) Submissions for Devices Labeled as Sterile #### 8. Clinical Test Conclusion No clinical study is included in this submission. {7}------------------------------------------------ # K192274 #### Substantially Equivalent (SE) Comparison 9. | Item | Proposed Device | Predicate Device K121995 | |---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | DZE | DZE | | Regulation Number | 21 CFR 872.3640 | 21 CFR 872.3640 | | Class | II | II | | Indication for Use | The BV Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-units restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. | The TS Fixture System is indicated for use in partially or fuilly edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.<br>TS Fixture System is compatible with abutment in the ET/SS Implant System | | Implant Type | Bone Level | Bone level | | Neck | No Neck | No Neck | | Structure | Internal Hex- connected<br>Submerged Implant<br>Tapered body shape and straight body shape<br>3 sided cutting edge with self-tapping for $φ$ 3.5 to $φ$ 5 implant<br>4 sided cutting edge with self-tapping for $φ$ 6 and $φ$ 7 implant | Internal Hex- connected<br>Submerged Implant<br>Tapered body shape and straight body shape<br>4 sided cutting edge with self-tapping | | Surgery type | One or two stage Surgery | One or two stage Surgery | | Surface Treatment | Sandblasting and Acid etching | Sandblasting and Acid etching | | Dental<br>Implants<br>diameter | 3.7, 4.2, 4.6, 5.1, 6.0, 6.8 | 3.5, 3.75, 3.77, 4.2, 4.25, 4.4, 4.6, 4.63, 4.65, 4.9, 5.05, 5.08, 5.1, 5.92, 5.95, 6, 6.8 | | Dental<br>Implants<br>length | For 3.7 mm implant (Mini)<br>Length 8.5~15 mm<br>For 4.2 to 5.1 mm implant (Regular)<br>Length 7.0~15 mm<br>For 6.0 and 6.8 mm implant (Regular)<br>Length 7.0~12.5 mm | For 3.5 mm implant<br>Length 8.5~15 mm<br>For 3.75 to 5.1 mm implant<br>Length: 7.0~15.0 mm<br>For 5.92 to 6.8mm implant<br>Length: 7.0~12.5 mm | | Dental implant type | Mini, Regular | Mini, Regular | | Transfer abutment | | | | | | | | Type | Mini, Regular | Mini, Regular | | Diameter (mm) | 4.6, 5.0, 6.0, 7.0 | 4.0, 4.6, 5.0, 6.0, 7.0 | | Height (mm) | 4.0, 5.5, 7.0 | 4.0, 5.5, 7.0 | | Angled abutment | | | | Type | Mini, Regular | Mini, Regular | | Diameter (mm) | 4.5, 5.0, 6.0 | 4.0, 4.5, 5.0, 6.0 | | Height (mm) | 8 | 8 | | Angle | 17° | 17° | | Temporary abutment | | | | Type | Mini, Regular | Mini, Regular | | Diameter (mm) | 4.0, 4.5 | 4.0, 4.5 | | Height (mm) | 10 | 10 | | G/H (mm) | 1.0, 3.0 | 1.0, 3.0 | | Multi angled abutment | | | | Type | Mini, Regular | Mini, Regular | | Diameter (mm) | 4.9 | 4.9 | | Height (mm) | 5, 5.1, 5.5, 5.6, 6, 6.1, 6.5, 6.6, 7.5, 7.6 | 5, 5.1, 5.5, 5.6, 6, 6.1, 6.5, 6.6, 7.5, 7.6 | | Angle | 17°, 30° | 17°, 30° | | Multi abutment | | | | Type | Mini, Regular | Mini, Regular | | Diameter (mm) | 4.8 | 4.8 | | Length (mm) | 8.3, 8.7, 9.3, 9.7, 10.3, 10.7, 11.3, 11.7,<br>12.3, 12.7 | 8.3, 8.7, 9.3, 9.7, 10.3, 10.7, 11.3, 11.7, 12.3, 12.7 | | Equator abutment | | | | Device | Proposed Device | Reference Device K182091 | | Diameter (mm) | 3.7 | 3.5, 3.7, 4.1, 4.8, 5.1 | | Length (mm) | 1, 2, 3, 4, 5, 6 | 1, 2, 3, 4, 5, 6, 7 | | Esthetic-low temporary cylinder | | | | Diameter (mm) | 4.8 | 4.8, 5.5 | | Height (mm) | 12 | 12 | | Healing abutment | | | | Type | Mini, Regular | Mini, Regular | | Diameter (mm) | 4.3, 4.8, 5.3, 5.5, 6.3, 7.3 | 4.3, 4.8, 5.3, 6.3, 7.3 | | Height (mm) | 3, 4, 5, 7, 9 | 3, 4, 5, 7, 9 | | Cover screw | | | | Diameter (mm) | 3.0, 3.6 | 3.0, 3.6 | | | | | | Height (mm) | 0.4, 1.4, 2.0 | 0.4, 1.4, 2.0 | | Equator healing abutment | | | | Diameter (mm) | 4.0 | 4.0 | | Height (mm) | 3.6, 5.6, 7.6 | 2.5, 4.5, 6.5 | | Bite index | | | | Diameter (mm) | 4.5, 5.5 | 4.5, 5.5 | | Height (mm) | 4, 6, 8, 10, 12 | 4, 6, 8, 10, 12 | | Esthetic-low Healing Cap | | | | Diameter (mm) | 4.8 | 4.8 | | Height (mm) | 6 | 6 | | Abutment screw | | | | Diameter (mm) | 2.2, 2.3 | 2.0, 2.05, 2.2, 2.3, 2.5 | | Length (mm) | 10.2, 8.05 | 3.35, 5.6, 7.5, 8.35, 9.6, 10.2 | | Occlusal screw | | | | Diameter (mm) | 2.5 | 2.0, 2.05, 2.2, 2.3, 2.5 | | Length (mm) | 4.0 | 3.35, 5.6, 7.5, 8.35, 9.6, 10.2 | | Material | | | | Dental Implant | Pure Titanium | Pure Titanium | | Abutment | Titanium Alloy | Titanium Alloy | | Healing Cap | Titanium Alloy | Titanium Alloy | | Sterilization | | | | Dental Implant | Irradiation sterilization | Irradiation sterilization | | Attachment | Non-sterile | Non-sterile | | Biocompatibility | | | | Device | Proposed Device | Reference Device K150388 | | Dental implant | Conform with ISO 10993 | Conform with ISO 10993 | | Abutment | No cytotoxicity | | # Table 1 Comparison of Proposed Device and Predicate Device {8}------------------------------------------------ {9}------------------------------------------------ S002 The indication for use for the proposed device is same as the predicate device K121995. In addition, two reference devices are also identified for comparison. The reference device K182091 was selected to comparing to the subject Equator Abutment. The reference device K150338 was selected to address the biocompability issue of the proposed device. - 10. Substantially Equivalent (SE) Conclusion Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate devices.