CreoDent Solidex Customized Abutment and Screw

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. CreoDent Prosthetics, Ltd. Calvin Shim Managing Director 29 West 30th Street, 11th Floor New York, New York 10001 Re: K220390 Trade/Device Name: CreoDent Solidex® Customized Abutment and Screw Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: October 19, 2022 Received: October 21, 2022 Dear Calvin Shim: 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 (QS) 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 mediation-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. # Andrew I. Steen -S Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT 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): K220390 Device Name: CreoDent Solidex® Customized Abutment and Screw Indication for Use: The CreoDent Solidex® Customized Abutment and Screw is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented, or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant. CreoDent Solidex Customized Abutments and Screws to be compatible with the Implant Direct InterActive/Swish Active 3.0mm implants are only indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The CreoDent Solidex® Customized Abutment is compatible with the following dental implants: | 510(k) | Manufacturer | Implant Line | Platform<br>Diameter (mm) | Implant Body<br>Diameter (mm) | |---------|--------------------------------------------|----------------------------------------|---------------------------|-------------------------------| | K163194 | Neodent Implant Systems | GM Line | 3.5/3.75 | 3.5/3.75 | | K143011 | Implant Direct Sybron<br>Manufacturing LLC | 2014 InterActive/SwishActive<br>System | 3.0 | 3.0 | Prescription Use X (Part 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) {3}------------------------------------------------ # K220390 510(k) Summary CreoDent Prosthetics, Ltd. 11/22/2022 #### ADMINISTRATIVE INFORMATION | Manufacturer Name | CreoDent Prosthetics, Ltd.<br>29 West 30th Street, 11th Floor<br>New York, New York 10001<br>Telephone: +1 212-302-3860 | |-------------------|-------------------------------------------------------------------------------------------------------------------------| | Official Contact | Calvin Shim – Managing Director<br>calvin.shim@creodental.com | #### DEVICE NAME AND CLASSIFICATION | Trade/Proprietary Name: | CreoDent Solidex® Customized Abutment and Screw | |-------------------------|-----------------------------------------------------------------------| | Common Name: | Abutment, Implant, Dental, Endosseous | | Regulation Name: | Endosseous dental implant abutment | | Regulation Number: | 21 CFR 872.3630 | | Device Code: | Class II | | Product Code: | NHA | | Review Panel: | Dental Products Panel | | Reviewing Branch: | Ophthalmic, Anesthesia, Respiratory, ENT and Dental Device<br>(OHT1B) | #### INDICATIONS FOR USE The CreoDent Solidex® Customized Abutment and Screw is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented, or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant. CreoDent Solidex Customized Abutments and Screws to be compatible with the Implant Direct InterActive/Swish Active 3.0mm implants are only indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The CreoDent Solidex® Customized Abutment is compatible with the following dental implants: | 510(k) | Manufacturer | Implant Line | Platform<br>Diameter (mm) | Implant Body<br>Diameter (mm) | |---------|--------------------------------------------|----------------------------------------|---------------------------|-------------------------------| | K163194 | Neodent Implant Systems | GM Line | 3.5/3.75 | 3.5/3.75 | | K143011 | Implant Direct Sybron<br>Manufacturing LLC | 2014 InterActive/SwishActive<br>System | 3.0 | 3.0 | #### DEVICE DESCRIPTION The Solidex® Customized Abutment and Screw is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 standard and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. Solidex® Customized Abutment and Screw are compatible with: | Manufacturer | Implant Line | Platform<br>Diameter<br>(mm) | Implant<br>Body<br>Diameter<br>(mm) | Max<br>Diameter | Wall<br>Thickness<br>(mm) | Height<br>Min/Max<br>(mm) | Post<br>Height<br>Min/Max<br>(mm) | Collar<br>Height<br>Min/Max<br>(mm) | Angulation<br>Min/Max<br>(Degress) | |-------------------------------|--------------|------------------------------|-------------------------------------|--------------------------------|---------------------------|---------------------------|-----------------------------------|-------------------------------------|------------------------------------| | Neodent<br>Implant<br>Systems | GM Line | 3.5/3.75 | 3.5/3.75 | 5mm<br>from<br>Implant<br>Axis | .68 | 5 - 10 | 4 - 9 | 1 - 5 | 0 - 20 | {4}------------------------------------------------ | Manufacturer | Implant Line | Platform<br>Diameter<br>(mm) | Implant<br>Body<br>Diameter<br>(mm) | Max<br>Diameter | Wall<br>Thickness<br>(mm) | Height<br>Min/Max<br>(mm) | Post<br>Height<br>Min/Max<br>(mm) | Collar<br>Height<br>Min/Max<br>(mm) | Angulation<br>Min/Max<br>(Degress) | |--------------------------------------------------|-------------------------------------------|------------------------------|-------------------------------------|--------------------------------|---------------------------|---------------------------|-----------------------------------|-------------------------------------|------------------------------------| | Implant Direct<br>Sybron<br>Manufacturing<br>LLC | 2014<br>InterActive/SwishActive<br>System | 3.0 | 3.0 | 5mm<br>from<br>Implant<br>Axis | .68 | 5 - 10 | 4 - 9 | 1 - 5 | 0 - 20 | The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist. Customization is limited by the minimum dimensions for wall thickness, diameter, height, collar height and angulation. # CAD/CAM Workflow The Solidex® Customized Abutment and Screw is CAD/CAM Patient Specific machine manufactured per prescription received from a dentist. The dentist will specify the implant type and size. Upon receiving the prescription from the dentist, CreoDent will only manufacture Solidex® Customized Abutment and Screw for which they have received FDA 510K clearance. Prescriptions can be submitted by mailing physical submissions to our office, or digital submissions can be uploaded to our online client portal. All submissions are entered under the client's specific accounts for record keeping and case tracking. Safeguards and limitation in the design software will be imposed according to specified design limitations built into abutment designer. Abutment blanks for each implant platform are produced to CreoDent Prosthetics, Ltd. specifications in Ti-6A1-4V Eli titanium alloy and Screw is CP TI Gr4 supplied by T.Strong INC, a Korean company located at 403, 433-8. Jangan-dong, Dongdeamun-gu, Seoul 130-100, Republic of Korea. T.Strong.INC obtains the abutment blank and screw materials from suppliers in the USA. All abutment blanks have prefabricated interfaces. CreoDent custom mills the non-interface portion of the abutment. T.Strong INC obtains titanium alloy and c.p. titanium from US suppliers and mills the abutment-to-implant connection platform according to the design specifications provided by CreoDent Prosthetics, Ltd. CreoDent Prosthetics finalizes the abutment device, according to a prescription provided by a dentist at the registered and listed CreoDent manufacturing facility in New York. {5}------------------------------------------------ ## EQUIVALENCE TO MARKETED DEVICE The Subject device is substantially equivalent in inciples to the predicate devices shown above. Below are summary the technological characteristics and the Indications for Use of the subject device abutments and the predicate device abutments. | Table 1A: Indications for Use Comparison with Predicate K150012 | | | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|-----------------------------------| | Subject Devices | Predicate Devices | | | | CreoDent Solidex® Customized Abutment | CreoDent Solidex® Customized Abutment<br>K150012 | | | | The CreoDent Solidex® Customized Abutment and Screw is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw-retained to the abutment. An abutment screw is used to secure the abutment to endosseous implant. CreoDent Solidex Customized Abutments and Screws to be compatible with the Implant Direct InterActive/Swish Active 3.0mm implants are only indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. | The CreoDent Solidex® Customized Abutment and Screw is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw-retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant.<br><br>The CreoDent Solidex® Customized Abutment is compatible with the following dental implants: | | | | The CreoDent Solidex® Customized Abutment is compatible with the following dental implants: | | | | | Manufacturer | Implant Line | Platform Diameter (mm) | Implant Body Diameter (mm) | | Neodent Implant Systems | GM Line | 3.5/3.75 | 3.5/3.75 | | Implant Direct Sybron Manufacturing LLC | 2014 InterActive/SwishActive System | 3.0 | 3.0 | | Manufacturer | Implant Line | Platform Diameter (mm) | Implant Body Diameter (mm) | | Implant Innovations | 3i Osseotite Certain Dental Implants | 3.25mm<br>4.0mm<br>5.0mm<br>6.0mm | 3.25mm<br>4.0mm<br>5.0mm<br>6.0mm | | Institut Straumann AG | Straumann Bone Level Implants | 3.3mm<br>4.1mm<br>4.8mm | 3.3mm<br>4.1mm<br>4.8mm | Tohle 14 : Indiaationafan Uga Ca Non-clinical Testing Data: Static/Farigue testing was condance with ISO 14801:2007E Dentisty-Implants-Dynamic fatigue test for endosseus dental implants with the worst-case scenario for the Screw comection platform. Reverse engineering dimensional analysis was conducted using OEM implant bodies, OEM abutnent screws, Sterlization validation was conducted according to ISO 17665-1 was performed. These results demonstrated that the Solider® Customized Abutment and Screw have sufficient mechanical stinical application and are compatible with Neodent GM Line InterActive/SwishActive System for which they are intended. Substantial Equivalence diseassion differences betwen the subject device and the Primary predicate is the compatible implant bodies. This comparison is for similarity of device not for implant compatibility. {6}------------------------------------------------ | Subject Devices | Reference Device | Refer Device | | | | | | | | | | | | | | | | | | | | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--| | CreoDent Solidex® Customized Abutment | Neodent Implant System<br>K163194 | Implant Direct - 2014 InterActive/SwishActive System<br>K143011 | | | | | | | | | | | | | | | | | | | | | | The CreoDent Solidex® Customized Abutment and<br>Screw is intended for use with an endosseous implant to<br>support a prosthetic device in patients who are partially or<br>completely edentulous. The device can be used for single<br>or multiple restorations. The prosthesis can be cemented<br>or screw-retained to the abutment. An abutment screw is<br>used to secure the abutment to endosseous implant.<br>CreoDent Solidex Customized Abutments and Screws to<br>be compatible with the Implant Direct InterActive/Swish<br>Active 3.0mm implants are only indicated for single-tooth<br>replacement of mandibular central and lateral incisors and<br>maxillary lateral incisors. The CreoDent Solidex®<br>Customized Abutment is compatible with the following<br>dental implants: | GM Exact Click Universal Abutments are<br>intermediary prosthetic components to be installed<br>onto GM implants to support the final prosthesis. They<br>provided in an anti-rotational shape for the coupling<br>with the prothesis and in various angulation, prosthetic<br>and gingival heights to match the variation in mucosal<br>thickness. They are indicated for cemented-retained<br>single-tooth prostheses onto implants.<br><br>Compatibility to: | GPS abutments are used in attachment-retained, tissue<br>supported restorations where the patient is fully or<br>partially edentulous in the arch to be restored. These<br>abutments are sold non-sterile with an accompanying<br><i>Instruction for Use</i> that provides clinicians with pre-use<br>sterilization instructions. These abutments are made form<br>Titanium 6AL-4V ELI with coronal region having a<br>Titanium Nitride (TiN) coating. The TiN coating process<br>was validated through cytotoxicity testing in accordance<br>with ISO 10993-5.<br><br>The Straight GPS abutments are a one-piece design<br>secured to the implant having identical interface features<br>as the previously cleared InterActive Ball Abutments. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Manufacturer Implant Line Platform Diameter (mm) Implant Body Diameter (mm) Neodent Implant Systems GM Line 3.5/3.75 3.5/3.75 | | | | | | | | | | | | | | | | | | | | | | | Manufacturer Implant Line Platform Diameter (mm) Implant Body Diameter (mm) Neodent Implant Systems GM Line 3.5/3.75 3.5/3.75 Implant Direct Sybron Manufacturing LLC 2014 InterActive/SwishActive System 3.0 3.0 | | | | | | | | | | | | | | Manufacturer Implant Line Platform Diameter (mm) Implant Body Diameter (mm) Implant Direct Sybron Manufacturing LLC 2014 InterActive/SwishActive System 3.0 3.0 | | | | | | | | | Table 1B: Indications for Use Comparison with Reference Devices Substantial Equivalence discussion difference between the subject device and the reference predicate is a stock abutment unable to be customized, while the Creo Dentized Abutment design of subject device is customized to the requirements of each patied by the prescribing dentist. Customization is limited by the mail thickness, diameter, height, collar height and angulation. Both Subject and Reference devices are compatible to the same implant system. {7}------------------------------------------------ | Parameter | Subject Devices<br>CreoDent Solidex®<br>Customized<br>Abutment | Predicate Devices<br>CreoDent Solidex®<br>Customized Abutment<br>K150012 | Reference Device<br>Neodent Implant<br>System - GM Line<br>K163194 | Reference Device<br>Implant Direct - 2014<br>InterActive/SwishActive<br>System<br>K143011 | Substantial<br>Equivalence | |----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------| | Product Code | NHA | NHA | NHA | NHA | Substantially<br>Equivalence | | Regulation Number | 872.3630 | 872.3630 | 872.3640 | 872.3640 | Substantially<br>Equivalence | | Regulatory Class | Class II | Class II | Class II | Class II | Substantially<br>Equivalence | | Abutment Material | Ti-6AL-4V ELI<br>(Grade 23) | Ti-6AL-4V ELI<br>(Grade 23) | Ti-6AL-4V ELI<br>(Grade 23) | Titanium Alloy | Substantially<br>Equivalence<br>To Predicate and<br>Reference devices. | | Screw Material | Ti-6AL-4V ELI<br>(Grade 23) | Ti-6AL-4V ELI<br>(Grade 23) | Ti-6AL-4V ELI<br>(Grade 23) | Titanium Alloy | Substantially<br>Equivalence<br>To Predicate and<br>Reference devices. | | Method Operation | Allows the prosthesis<br>to be cemented or<br>screw-retained to the<br>abutment. The<br>abutment screw is<br>designed to secure<br>the abutment to the<br>endosseous implant. | Allows the prosthesis<br>to be cemented or<br>screw-retained to the<br>abutment. The<br>abutment screw is<br>designed to secure the<br>abutment to the<br>endosseous implant | Allows the prosthesis<br>to be cemented or<br>screw-retained to the<br>abutment. The<br>abutment screw is<br>designed to secure the<br>abutment to the<br>endosseous implant. | Allows the prosthesis to<br>be cemented or screw-<br>retained to the abutment.<br>The abutment screw is<br>designed to secure the<br>abutment to the<br>endosseous implant. | Substantially<br>Equivalence | | Compatible Implant<br>Systems - Implant<br>Diameter (mm) | Neodent GM<br>3.5/3.75mm<br>Implant Direct<br>InterActive/Swish<br>Active 3.0mm | Biomet 3i Osseotite<br>Certain Dental<br>Implants 3.25mm,<br>4mm, 5mm, 6mm<br>Straumann Bone Level<br>implants 3.3mm.<br>4.1mm, 4.8mm | Neodent GM<br>3.5/3.75mm | Implant Direct<br>InterActive/Swish<br>Analog 3.0mm | Substantially<br>Equivalence<br>By means of<br>combing Predicate<br>and Reference<br>device compatible<br>implant systems | Technical Characteristics Substantial Equivalence Comparison Table Substantial Equivalence discussion difference between the subject device and the reference predicate is a stock abutneti unable to be customized, while the CreoDent Solided Abutnent design of subject device is customized to the requirements of each patient as nay be specified by the prescribing dentist. Customization is limited by the minimum dimensions for wall thickness, diameer, height, and Subject and Reference devices are compatible to the same implant system. {8}------------------------------------------------ ## CLINICAL TESTING No clinical data is included in this submission. ### NON-CLINICAL PERFORMANCE TESTING Static/Fatigue testing was conducted in accordance with ISO 14801:2007 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst-case scenario for the CreoDent Solidex® Customized Abutment and Screw connection platform. Reverse engineering dimensional analysis using OEM compatible implant bodies, abutment fixation screws. Sterilization validation according to ISO 17665-1 was performed. These results demonstrated that the CreoDent Solidex® Customized Abutment and Screw have sufficient mechanical strength for their intended clinical application. The Solidex® Customized Abutment and Screw are Ti-6A1-4V Eli titanium alloy and meets ASTM F-136 Standard. These grades of materials have a common use in surgical implants. Further evaluation for potential cytotoxic effects conducted in accordance with ISO 10993-5, Biological evaluation of medical devices - Part 5:Test for in vitro cvtotoxicity showed no evidence of causing cell lysis or toxicity. Therefore, we believe there are no special biocompatibility data requirements. Non-clinical worst-case MRI review was performed to evaluate the metallic CreoDent Solidex® Customized Abutment and Screw devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material compositions. The rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque. #### CONCLUSION Overall, the Subject device has the following similarities to the legally marketed Predicate and Reference devices: They have nearly the same Indications of Use. They have the same Intended Use. The have the same Technological Characteristics. Overall, the Subject device and Predicate devices have been demonstrated to be Substantially Equivalent.