(91 days)
No
The document describes a dental implant system and its components. There is no mention of AI or ML technology in the intended use, device description, or performance studies. The focus is on the physical design, materials, and mechanical performance of the implants and abutments.
Yes
The device is a dental implant system used to replace missing teeth and restore chewing function and aesthetics, which are therapeutic interventions.
No
Explanation: The device is an endosseous dental implant system used for replacing missing teeth and restoring chewing function and aesthetics. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is an endosseous root-form dental implant system, which is a physical hardware device made of titanium alloy. It also mentions associated compatible abutments, screws, and other accessory components, all of which are physical hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical procedure for replacing missing teeth and supporting prosthetic devices. This is a direct medical intervention on the patient's body.
- Device Description: The device is described as an "endosseous root-form dental implant" and associated components that are surgically implanted.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological or pathological state.
- Being used in vitro (outside the body).
The device is a surgically implanted medical device used to restore function and aesthetics, not to perform diagnostic testing on biological samples.
N/A
Intended Use / 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 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.
Product codes
DZE
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.
Implants 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibles and/or maxillae (upper or lower jaw)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Biological Evaluation of the Subject device was performed according to ISO 10993-1.
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 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.
Overall, minor differences in the designs, dimensions, or sizes between the Subject device, and the Reference devices do not affect substantial equivalence.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3640 Endosseous dental implant.
(a)
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.(b)
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.
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)
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)
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4
510(k) Summary Keystone DentalInc. Prima Conical Implant System K240966
Administrative Information
| Manufacturers Name: | Keystone Dental Inc. | |
|---|---|---|
| 154 Middlesex Turnpike | ||
| 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 | |
| Line | Neodent Implant Systems | |
| K180536 | Neodent Implant System – GM | |
| 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 | ||
| (mm) | Implant Platform | ||
| Diameter (mm) | Lengths (mm) | ||
| Prima Plus | |||
| 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.
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| Device | Indications for Use Statement |
|---|---|
| Subject Device | |
| Prima Plus Conical | |
| 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. |
All digitally designed custom abutments for use with Prima Plus™ Conical Implant Systemimplantsareto besenttoa Keystone Dentalvalidatedmillingcenterfor manufacture. |
| Predicate Device
Genesis ACTIVE Implant
System
(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.
All digitally designedcustomabutments for use with Genesis ACTIVElmplant System implantsaretobesenttoa KeystoneDentalvalidatedmillingcenterformanufacture.
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
Paltop Conical Implant
System
(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
Neodent Implant System-
GM Line
(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) |
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Comparison of TechnologicalCharacteristics
| Design Parameter | Subject Device: Prima
Plus Conical Implant
System
Keystone Dental Inc. | Predicate Device:
Genesis ACTIVE Implant
System (K223814)
Keystone Dental Inc. | Reference Device: Paltop
Conical Implant System
(K220200)
Paltop Advanced Dental
Solutions | Reference Device:
Neodent Implant System
GM Line (K163194)
Neodent Implant Systems | Reference Device:
Neodent Implant System
GM Line (K180536)
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
F67) | TitaniumGrade 4 (ASTM
F67) |
| Implant Surface
Treatment | Sand-blasted, Large Grit,
Acid-Ethched (SLA) | BioSpark, AnaTite
Blasted, Hydrophillic
Surface Enriched with
Calcium and
Phospthorous lons | Sand-blasted, Large Grit,
Acid-Ethched (SLA) | Neoporos: rough surface
created using an abrasive
particle jet concept with
controlled grain oxides,
followed by acid etching
creating uniform cavities
in the implant surface. | Neoporos: rough surface
created using an abrasive
particle jet concept with
controlled grain oxides,
followed by acid etching
creating uniform cavities
in the implant surface. |
| Reason for Predicate
Reference | N/A | Implant Diameters,
Lengths, Sterilization,
Indications for Use | Implant Diameters,
Sterilization, Implants
Modified Surface,
Sterilization,
Biocompatibility | Implant Diameters (8mm
length with 3.5mm
diameter) | Implant Diameters |
| Design Parameter | Subject Device: Prima
Plus Conical Implant
System
Keystone Dental Inc. | Predicate Device:
Genesis ACTIVE Implant
System (K223814)
Keystone Dental Inc. | Reference Device: Paltop
Conical Implant System
(K220200)
Paltop Advanced Dental
Solutions | Reference Device:
Neodent Implant System -
GM Line (K163194)
Neodent Implant Systems | Reference Device:
Neodent Implant System
GM Line (K180536)
Neodent Implant Systems |
| D= Implant Body
Diameter
IP - Implant Platform
Diameter (mm)
Length (mm) | Endosseous screw-type
implant with internal
connection, Beveled
collar, parallel wall non-
threaded neck, tapered
body with a double lead v-
threaded and an
active/cutting apex.
D = 3.5, IP = 3.25, Lengths
= 8, 10, 11.5, 13, 15
D = 4.1, IP = 3.7, Lengths =
8, 10, 11.5, 13, 15
D = 5.0, IP = 4.47, Lengths
= 8.0, 10, 11.5, 13, 15
D = 6.0, IP = 5.5, Lengths =
8, 10, 11.5, 13 | Endosseous screw-type
implant with internal
connection, Beveled
collar, parallel wall non-
threaded neck, tapered
body with a double lead v-
threaded and an
active/cutting apex.
D = 3.5, IP = 3.2, Lengths
= 10, 11.5, 13, 16
D = 3.8, IP = 3.2, Lengths
= 8.5, 10, 11.5, 13, 16
D = 4.5, IP = 3.2, Lengths =
8.5, 10, 11.5, 13, 16
D = 5.5, IP = 3.2, Lengths
= 8.5, 10, 11.5, 13 | Endosseous screw-type
implant with internal
connect. Parallel coronal
and midsection, micro
threads on neck, reverse
buttress thread in mid-
section tapering to an
active/cutting apex.
Platform switching taper
on implant top level
D = 3.25, IP = 3.25, Lengths
= 10, 11.5, 13, 16
D = 3.75, IP = 3.75, Lengths
= 8, 10, 11.5, 13, 16
D = 4.2, IP = 4.2. Lengths =
8, 10, 11.5, 13,16
D = 5.0, IP = 5.0, Lengths =
8, 10, 11.5, 13,16 | Endosseous screw-type
implant with internal
connect. Morse taper
implant-to-
abutment interface with
an internal hexagonal
connection.
D = 3.50, Lengths = 8, 10,
11.5, 13, 16 and 18
D = 3.75, Lengths = 8, 10,
11.5, 13, 16 and 18
D = 4.3, Lengths = 8, 10,
11.5, 13, 16 and 18
D = 5.0, Lengths = 8, 10,
11.5, 13, 16 and 18 | Endosseous screw-type
implant with internal
connect. Morse taper
implant-to-abutment
interface with an interna
hexagonal connection.
D = 6, Lengths = 8, 10,
11.5, 13 |
| Mode of Operation | Provides support for
prosthetic devices, such
as artificial teeth, to
restore the patients
chewing function | Provides support for
prosthetic devices, such
as artificial teeth, to
restore the patients
chewing function | Provides support for
prosthetic devices, such
as artificial teeth, to
restore the patients
chewing function | Provides support for
prosthetic devices, such
as artificial teeth, to
restore the patients
chewing function | Provides support for
prosthetic devices, such
as artificial teeth, to
restore the patients
chewing function |
| Implant Material | Titanium Ti-6Al-4V ELI | (CP-4 Titanium) Class 4
Titanium | Titanium Ti-6Al-4V ELI | (CP-4 Titanium) Class 4
Titanium | (CP-4 Titanium) Class 4
Titanium |
| Implant Surface Treatment | Sand-blasted, Large Grit,
Acid-Etched (SLA) | BioSpark, AnaTite Blasted,
Hydrophillic Surface
Enriched with Calcium and
Phospthorous Ions | Sand-blasted, Large Grit,
Acid-Etched (SLA) | Neoporos: rough surface
created using an abrasive
particle jet concept with
controlled grain oxides,
followed by acid etching
creating uniform cavities
in the implant surface. | Neoporos: rough surface
created using an abrasive
particle jet concept with
controlled grain oxides,
followed by acid etching
creating uniform cavities
in the implant surface. |
| Sterilization Method | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization | Gama Sterilization | Gama Sterilization |
| Implant/Abutment Interface | Hex internal interface with
coronal conical taper | Hex internal interface with
coronal conical taper | Hex internal interface with
coronal conical taper | Internal Interface 16
Degree Morse taper
with anti-rotational
features. | Internal Interface 16
Degree Morse taper with
anti-rotational features. |
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Technological Characteristics Comparison Table - Implant Design
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