← Product Code [DZE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE) · K240966 # Prima Plus Conical Implant System (K240966) _Keystone Dental, Inc. · DZE · Jul 9, 2024 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE/K240966 ## Device Facts - **Applicant:** Keystone Dental, Inc. - **Product Code:** [DZE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE.md) - **Decision Date:** Jul 9, 2024 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3640 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Intended Use The Prima Plus™ Conical Implant System is intended for use in single-stage or two-stage surgical procedures for replacing single or multiple missing teeth in partially or fully edentulous mandibles and/or maxillae. The Prima Plus™ Conical Implant System supports single or multiple-unit restorations to re-establish patient chewing function and aesthetics. Prima Plus™ Conical implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket. Immediate function may be achieved when good primary stability is established, and appropriate occlusal loading is applied. All digitally designed custom abutments for use with Prima Plus™ Conical Implant System implants are to be sent to a Keystone Dental validated milling center for manufacture. ## Device Story Endosseous root-form dental implant system; titanium alloy (Ti-6Al-4V ELI) construction; SLA surface treatment. Used by dental surgeons in clinical settings to replace missing teeth; provides support for prosthetic restorations (crowns, bridges, overdentures). Implant surgically placed into jawbone; compatible with various abutments (healing, straight, angled, multi-unit, PEEK temporary, titanium temporary). Prosthetic devices can be screw-retained or cement-retained. System restores patient chewing function and aesthetics. Digitally designed custom abutments require manufacturing at validated milling centers. Device provides mechanical foundation for dental prosthetics; benefits patient by restoring oral function and appearance. ## Clinical Evidence No clinical data were included in this submission. Substantial equivalence is supported by bench testing, including fatigue testing per ISO 14801:2016 on worst-case constructs, and biocompatibility evaluation per ISO 10993-1. ## Technological Characteristics Endosseous screw-type dental implant; material: Titanium-6Aluminum-4Vanadium ELI (ASTM F136); surface: Sandblasted, Large grit, Acid-etched (SLA); sterilization: Gamma irradiation; interface: Hex internal with coronal conical taper; diameters: 3.5mm to 6.0mm; lengths: 8mm to 15mm. ## Regulatory Identification An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function. ## Special Controls *Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use. ## Predicate Devices - Genesis Active Implant System ([K223814](/device/K223814.md)) ## Reference Devices - Paltop Conical Implant System ([K220200](/device/K220200.md)) - Neodent Implant System – GM Line ([K163194](/device/K163194.md)) - Neodent Implant System – GM Line ([K180536](/device/K180536.md)) ## Related Devices - [K233163](/device/K233163.md) — ZENEX Implant System_Short · Izenimplant Co., Ltd. · Dec 19, 2023 - [K202046](/device/K202046.md) — LOTA SLA Dental Implant System and LOTA HA Dental Implant System · Kj Meditech Co., Ltd. · Mar 1, 2022 - [K031055](/device/K031055.md) — ITI DENTAL IMPLANT SYSTEM · Straumann USA · Jul 7, 2003 - [K112440](/device/K112440.md) — AB DENTAL DEVICES IMPLANTS AND ACCESSORIES · A.B. Dental Devices , Ltd. · Apr 18, 2012 - [K222142](/device/K222142.md) — BR SLA Type Implant System · Biotem Co., Ltd. · Jun 24, 2023 ## Submission Summary (Full Text) {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 9, 2024 Keystone Dental Inc. Adam Johnson Regulatory Affairs Manager 154 Middlesex Turnpike Burlington, Massachusetts 01803 Re: K240966 Trade/Device Name: Prima Plus Conical Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: April 8, 2024 Received: April 9, 2024 ## Dear Adam Johnson: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. {2}------------------------------------------------ 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-regulatory- assistance/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 Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use Submission Number (if known) K240966 Device Name Prima Plus Conical Implant System #### Indications for Use (Describe) The Prima Plus™ Conical Implant System is intended for use in single-stage or two-stage surgical procedures for replacing single or multiple missing teeth in partially or fully edentulous mandibles and/or maxillae. The Prima Plus™ Conical Implant System supports single or multiple-unit restorations to re-establish patient chewing function and aesthetics. Prima Plus™ Conical implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket. Immediate function may be achieved when good primary stability is established, and appropriate occlusal loading is applied. All digitally designed custom abutments for use with Prima Plus™ Conical Implants are to be sent to a Keystone Dental validated milling center for manufacture. 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." {4}------------------------------------------------ ## 510(k) Summary Keystone DentalInc. Prima Conical Implant System K240966 #### Administrative Information | Manufacturers Name: | Keystone Dental Inc. | | |---------------------|------------------------------------------------|-----------------------------| | | 154 Middlesex Turnpike<br>Burlington, MA 01803 | | | | | | | | Telephone: | +1 (781)328-3490 | | | Fax: | +1 (781)328-3400 | | | | | | Official Contact: | Adam Johnson, Regulatory Affairs Manager | | | | Email: | zjohnson@keystonedental.com | | | Telephone: | +1 (916) 203-1977 | Date Submitted: July 3, 2024 ### Device Name and Classification | Trade/Proprietary Name: | Prima Plus Conical Implant System | |----------------------------|--------------------------------------------| | Common Name: | Implant,Dental,Endosseous,Root-Form | | Classification Name: | Endosseous dental implant | | Classification Regulation: | 21 CFR872.3640 | | Device Class: | Class II | | Product Code: | DZE | | Review Panel: | Dental | | Review Division: | DHT1B – Division of Dental and ENT Devices | ### Predicate and Reference Device Information The devices within this submission are substantially equivalent in indications, intended use and design principals to the following legally marketed predicate device. | 510(k) | Predicate Device Name | Company Name | |---------|-------------------------------|----------------------| | K223814 | Genesis Active Implant System | Keystone Dental Inc. | The following reference devices are used to support the technological characteristics of the subject device | 510(k) | Reference Device Name | Company Name | |---------|-------------------------------------|---------------------------------------| | K220200 | Paltop Conical Implant System | Paltop Advanced Dental Solutions, Ltd | | K163194 | Neodent Implant System – GM<br>Line | Neodent Implant Systems | | K180536 | Neodent Implant System – GM<br>Line | Neodent Implant Systems | {5}------------------------------------------------ ## Device Description The purpose of this submission is for the marketing clearance for Prima Plus Conical Implants, an endosseous root-form dental implant. The overall system is designed to be used with compatible components and are indicated for single-unit, multi-unit and overdenture restorations. No new prosthetic components were designed as part of this submission, with these implants designed to be compatible with previously cleared prosthetic components. Endosseous dental implants are surgically implanted into a patient's mouth to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Endosseous dental implant abutments are secured to dental implants with a retaining screw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Prosthetic devices used with the dental implant abutments in this submission may be screw-retained or cement-retained. The Prima Plus Conical Implant System includes endosseous screw type dental implants which can be used in either single- or two-stage surgeries with associated compatible abutments, screws, and other associated accessory components. The Prima Plus Conical Includes previously marketed abutments with fifteen (1 5) designs: Healing Abutments, Straight (with and without TiPink), Angled (with and without TiPink), Straight Multi-Unit, Angled Multi-Unit, PEEK Straight Temporary, PEEK Angled Temporary, Temporary Cylinder (with and without TiPink), Titanium Temporary Immediate (with and without TiPink), Titanium Blank. There are four minor variations of the Titanium Base design: Ti-Base, C-Base®, and ELLIPTIBase®. Prosthetic devices used with the dental implant abutments in this submission may be screw-retained or cemented. lmplants are fabricated from a Titanium 4 Vanadium ELI titanium alloy which conforms to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI Alloy for Surgical Implant Applications (UNS R56401). They have a Sandblasted, Large grit and Acid-etched (SLA) surface treatment. All implants are one-time use devices All Subject device components are provided sterilized by gamma irradiation. | Prima Plus Conical Implant System - Implant Sizes | | | | |---------------------------------------------------|--------------------------|-----------------------------------|---------------------| | Implant Type | Implant Diameter<br>(mm) | Implant Platform<br>Diameter (mm) | Lengths (mm) | | Prima Plus<br>Conical | $\varnothing$ 3.5 | 3.25 | 8, 10, 11.5, 13, 15 | | | $\varnothing$ 4.1 | 3.71 | 8, 10, 11.5, 13, 15 | | | $\varnothing$ 5.0 | 4.47 | 8, 10, 11.5, 13, 15 | | | $\varnothing$ 6.0 | 5.50 | 8, 10, 11.5, 13 | #### Prima Plus Conical Implant System - Implant Sizes ### Indications for Use The Prima Plus™ Conical Implant System is intended for use in single-stage or two-stage surgical procedures for replacing single or multiple missing teeth in partially or fully edentulous mandibles and/or maxillae. The Prima Plus™ Conical Implant System supports single or multiple-unit restorations to re-establish patient chewing function and aesthetics. Prima Plus™ Conical implants are intended for placement following natural tooth loss or for immediate placement into extraction socket. Immediate function may be achieved when good primary stability is established, and appropriate occlusal loading is applied. All digitally designed custom abutments for use with Prima Plus™ System implants are to be sent to a Keystone Dental validated milling center for manufacture. ### Equivalence to Marketed Device Substantial equivalence is claimed with the Predicate devices are being used to support the expansion of technologies which differ between the Subject and Predicate devices. Provided at the end of this section is a table which compare the Indications for Use Statements and additional tables comparing the {6}------------------------------------------------ technological characteristics of the Subject, Predicate and Reference devices. ### Technological Characteristics Overall, the Subject device implants are highly similar to the Predicate and Reference device implant material and surface treatment are identical to the sponsor's Reference Predicate K220200 with Implant diameters and lengths supported by the Predicate K223814. The range of Subject device implant diameters are supported by the Predicate and Reference device implants are single-use, single-use, single user, the same as the Predicate device. The slight changes in implant thread design does not affect substantial equivalence nor change the intended use of the devices. Sterilization and packaging of the sterile Subject device implants and screws are the same as the K220200 Reference device. Please note that Paltop Dental is wholly owned by Keystone Dental Group and therefore, referenced Paltop products (K220200) are part of Keystone Dental Company. ### Non-Clinical Performance Testing Fatigue testing was performed according to the requirements of ISO 14801:2016, Dentistry – Implants – Dynamic loading test for Endosseous Dental Implants. The worst-case scenario was chosen based on the FDA Guidance, Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. The Subject devices have the same nature of body contact duration, material formulation and sterilization methods compared to the sponsor's Predicate and Reference devices. Biological Evaluation of the Subject device was performed according to ISO 10993-1. Sterilization information, including method, process, location, shelf life, pyrogenicity testing, and packaging is leveraged from the K220200 submission. The subject devices are made of identical materials and manufacturing as the K220200 submission, including SLA surface treatment, so nonew biocompatibility or surface evaluation testing was determined to be necessary. Benchtop performance testing on the worst-case constructs was conducted per ISO 14801 and the recommendations of the FDA special controls document. The results of the non-clinical testing demonstrate conformance with testing requirements and support a finding of substantial equivalence. Non-clinical worst-case MRI review was performed to evaluate the Subject device components 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 Page 7 of 20 variations (all compatible implant bodies, abutments, and material composition. 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. No clinical data were included in this submission. ### Conclusion Overall, minor differences in the designs, dimensions, or sizes between the Subject device, and the Reference devices do not affect substantial equivalence. {7}------------------------------------------------ Implant designs are supported by the similar Predicate device. Overall, the Subject, Predicate and Reference devices encompass a similar range of physical dimensions. Minor differences related to implant designs are mitigated by mechanical performance testing. ISO 14801 mechanical performance testing was performed on worst-case constructs of the Subject device to demonstrate suitability for intended use of the Subject device. The Indications for Use statements for the Subject and Predicate devices are identical, except for the device name and the inclusion of an additional device in the K223814 submission, which is not included in the subject. The Technological Characteristics, mode of operation and materials of the Subject device are the same or highly similar to that of the Predicate and Reference Predicate devices. Slight differences in design dimensions do not affect the intended use of the device and are mitigated and/or supported through Reference devices and non-clinical performance testing results. ISO 14801 mechanical performance testing performed on worst-case constructs of the Subject device to demonstrate suitability for intended use of the Subject device implant platform, gingival height, and post correction angles combinations. Overall, the data included in this premarket notification demonstrate substantial equivalence of Subject device to the sponsor's Predicate device. The basis for the belief that the Subject device is substantially equivalent to the Predicate device and is summarized in the following comparison tables. {8}------------------------------------------------ | Device | Indications for Use Statement | |---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Subject Device<br>Prima Plus Conical<br>Implant System | The Prima Plus™ Conical Implant System is intended for use in single-stage or two- stage surgical proceduresforreplacing single ormultiplemissing teethinpartially or fully edentulous mandibles and/or maxillae. The Prima Plus™ Conical Implant System supportssingleormultiple-unitrestorationstore-establish patient chewingfunction and aesthetics. Prima Plus™ Conical implants are intended for placement following natural toothlossorforimmediate placementintoanextraction socket.Immediate functionmaybeachievedwhengood primarystabilityisestablished, andappropriate occlusal loading is applied.<br><br>All digitally designed custom abutments for use with Prima Plus™ Conical Implant Systemimplantsareto besenttoa Keystone Dentalvalidatedmillingcenterfor manufacture. | | Predicate Device<br>Genesis ACTIVE Implant<br>System<br>(K223814) | The Genesis ACTIVE Implant System is intendedforuseinsingle-stage ortwo-stage surgicalproceduresforreplacingsingleormultiplemissingteethinpartially orfully edentulous mandibles and maxillae. The Genesis ACTIVE Implant System supports single ormultiple-unitrestorationstore-establish patient chewingfunctionand esthetics. Genesis ACTIVE implants are intended for placement following natural toothlossorforimmediateplacementintoanextractionsocket.Immediatefunction may be achieved when good primary stability is established, and appropriate occlusal loading is applied.<br><br>All digitally designedcustomabutments for use with Genesis ACTIVElmplant System implantsaretobesenttoa KeystoneDentalvalidatedmillingcenterformanufacture.<br><br>The KDG-Osteon Precision Milled Suprastructure is indicated for attachment to the Genesis ACTIVE Multi-Unit abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The KDG-Osteon Precision Milled Suprastructure is intended for attachment to a minimum of two (2) abutments. | | Reference Device<br>Paltop Conical Implant<br>System<br>(K220200) | The Paltop Conical Implant System is indicatedforuseinsurgical and restorative applicationsforplacementintheboneoftheupperorlowerjawtoprovidesupport forprosthetic devices, suchas artificial teeth, inordertorestore thepatient's chewingfunction. Narrow diameterimplantsareintendedforplacementinthe mandibularcentral, lateral incisorandmaxillary lateralincisor regionsofpartially edentulous jaws wherethe horizontal spaceislimited by the adjacent teeth and roots. The Paltop Conical Implant System isalsoindicatedforimmediateloading when good primary stability is achieved and with appropriate occlusal loading. | | Reference Device<br>Neodent Implant System-<br>GM Line<br>(K163194) | The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. | {9}------------------------------------------------ | Reference Device | The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. | |------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Neodent Implant System-GM Line (K180536) | | {10}------------------------------------------------ # Comparison of TechnologicalCharacteristics | Design Parameter | Subject Device: Prima<br>Plus Conical Implant<br>System<br>Keystone Dental Inc. | Predicate Device:<br>Genesis ACTIVE Implant<br>System (K223814)<br>Keystone Dental Inc. | Reference Device: Paltop<br>Conical Implant System<br>(K220200)<br>Paltop Advanced Dental<br>Solutions | Reference Device:<br>Neodent Implant System<br>GM Line (K163194)<br>Neodent Implant Systems | Reference Device:<br>Neodent Implant System<br>GM Line (K180536)<br>Neodent Implant Systems | |--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulation Number # | 21 CFR 872.3640 | 21 CFR 872.3640 | 21 CFR 872.3640 | 21 CFR 872.3640 | 22 CFR 872.3640 | | Product Code | DZE | DZE, NHA | DZE, NHA | DZE, NHA | DZE, NHA | | Classification | Class II | Class II | Class II | Class II | Class II | | Materials | Titanium Ti-6Al-4V ELI | CP 4 Titanium (ASTM F67) | Titanium Ti-6Al-4V ELI | TitaniumGrade 4 (ASTM<br>F67) | TitaniumGrade 4 (ASTM<br>F67) | | Implant Surface<br>Treatment | Sand-blasted, Large Grit,<br>Acid-Ethched (SLA) | BioSpark, AnaTite<br>Blasted, Hydrophillic<br>Surface Enriched with<br>Calcium and<br>Phospthorous lons | Sand-blasted, Large Grit,<br>Acid-Ethched (SLA) | Neoporos: rough surface<br>created using an abrasive<br>particle jet concept with<br>controlled grain oxides,<br>followed by acid etching<br>creating uniform cavities<br>in the implant surface. | Neoporos: rough surface<br>created using an abrasive<br>particle jet concept with<br>controlled grain oxides,<br>followed by acid etching<br>creating uniform cavities<br>in the implant surface. | | Reason for Predicate<br>Reference | N/A | Implant Diameters,<br>Lengths, Sterilization,<br>Indications for Use | Implant Diameters,<br>Sterilization, Implants<br>Modified Surface,<br>Sterilization,<br>Biocompatibility | Implant Diameters (8mm<br>length with 3.5mm<br>diameter) | Implant Diameters | | Design Parameter | Subject Device: Prima<br>Plus Conical Implant<br>System<br>Keystone Dental Inc. | Predicate Device:<br>Genesis ACTIVE Implant<br>System (K223814)<br>Keystone Dental Inc. | Reference Device: Paltop<br>Conical Implant System<br>(K220200)<br>Paltop Advanced Dental<br>Solutions | Reference Device:<br>Neodent Implant System -<br>GM Line (K163194)<br>Neodent Implant Systems | Reference Device:<br>Neodent Implant System<br>GM Line (K180536)<br>Neodent Implant Systems | | D= Implant Body<br>Diameter<br>IP - Implant Platform<br>Diameter (mm)<br>Length (mm) | Endosseous screw-type<br>implant with internal<br>connection, Beveled<br>collar, parallel wall non-<br>threaded neck, tapered<br>body with a double lead v-<br>threaded and an<br>active/cutting apex.<br>D = 3.5, IP = 3.25, Lengths<br>= 8, 10, 11.5, 13, 15<br>D = 4.1, IP = 3.7, Lengths =<br>8, 10, 11.5, 13, 15<br>D = 5.0, IP = 4.47, Lengths<br>= 8.0, 10, 11.5, 13, 15<br>D = 6.0, IP = 5.5, Lengths =<br>8, 10, 11.5, 13 | Endosseous screw-type<br>implant with internal<br>connection, Beveled<br>collar, parallel wall non-<br>threaded neck, tapered<br>body with a double lead v-<br>threaded and an<br>active/cutting apex.<br>D = 3.5, IP = 3.2, Lengths<br>= 10, 11.5, 13, 16<br>D = 3.8, IP = 3.2, Lengths<br>= 8.5, 10, 11.5, 13, 16<br>D = 4.5, IP = 3.2, Lengths =<br>8.5, 10, 11.5, 13, 16<br>D = 5.5, IP = 3.2, Lengths<br>= 8.5, 10, 11.5, 13 | Endosseous screw-type<br>implant with internal<br>connect. Parallel coronal<br>and midsection, micro<br>threads on neck, reverse<br>buttress thread in mid-<br>section tapering to an<br>active/cutting apex.<br>Platform switching taper<br>on implant top level<br>D = 3.25, IP = 3.25, Lengths<br>= 10, 11.5, 13, 16<br>D = 3.75, IP = 3.75, Lengths<br>= 8, 10, 11.5, 13, 16<br>D = 4.2, IP = 4.2. Lengths =<br>8, 10, 11.5, 13,16<br>D = 5.0, IP = 5.0, Lengths =<br>8, 10, 11.5, 13,16 | Endosseous screw-type<br>implant with internal<br>connect. Morse taper<br>implant-to-<br>abutment interface with<br>an internal hexagonal<br>connection.<br>D = 3.50, Lengths = 8, 10,<br>11.5, 13, 16 and 18<br>D = 3.75, Lengths = 8, 10,<br>11.5, 13, 16 and 18<br>D = 4.3, Lengths = 8, 10,<br>11.5, 13, 16 and 18<br>D = 5.0, Lengths = 8, 10,<br>11.5, 13, 16 and 18 | Endosseous screw-type<br>implant with internal<br>connect. Morse taper<br>implant-to-abutment<br>interface with an interna<br>hexagonal connection.<br>D = 6, Lengths = 8, 10,<br>11.5, 13 | | Mode of Operation | Provides support for<br>prosthetic devices, such<br>as artificial teeth, to<br>restore the patients<br>chewing function | Provides support for<br>prosthetic devices, such<br>as artificial teeth, to<br>restore the patients<br>chewing function | Provides support for<br>prosthetic devices, such<br>as artificial teeth, to<br>restore the patients<br>chewing function | Provides support for<br>prosthetic devices, such<br>as artificial teeth, to<br>restore the patients<br>chewing function | Provides support for<br>prosthetic devices, such<br>as artificial teeth, to<br>restore the patients<br>chewing function | | Implant Material | Titanium Ti-6Al-4V ELI | (CP-4 Titanium) Class 4<br>Titanium | Titanium Ti-6Al-4V ELI | (CP-4 Titanium) Class 4<br>Titanium | (CP-4 Titanium) Class 4<br>Titanium | | Implant Surface Treatment | Sand-blasted, Large Grit,<br>Acid-Etched (SLA) | BioSpark, AnaTite Blasted,<br>Hydrophillic Surface<br>Enriched with Calcium and<br>Phospthorous Ions | Sand-blasted, Large Grit,<br>Acid-Etched (SLA) | Neoporos: rough surface<br>created using an abrasive<br>particle jet concept with<br>controlled grain oxides,<br>followed by acid etching<br>creating uniform cavities<br>in the implant surface. | Neoporos: rough surface<br>created using an abrasive<br>particle jet concept with<br>controlled grain oxides,<br>followed by acid etching<br>creating uniform cavities<br>in the implant surface. | | Sterilization Method | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization | Gama Sterilization | Gama Sterilization | | Implant/Abutment Interface | Hex internal interface with<br>coronal conical taper | Hex internal interface with<br>coronal conical taper | Hex internal interface with<br>coronal conical taper | Internal Interface 16<br>Degree Morse taper<br>with anti-rotational<br>features. | Internal Interface 16<br>Degree Morse taper with<br>anti-rotational features. | {11}------------------------------------------------ # Technological Characteristics Comparison Table - Implant Design {12}------------------------------------------------ --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE/K240966](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE/K240966) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE/K240966