(135 days)
S.I.N. Dental Implant System Zygomatic implants are intended for placement in the maxillary arch to provide support for fixed or removable dental prostheses in patients with partially or fully edentulous maxillae. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System Zygomatic implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The purpose of this submission is to add components to the S.I.N. Dental Implant System. This submission includes zygomatic dental implants and mating abutments for screw-retained, multi-unit prostheses.
The subject device Zygomatic Plus Morse Taper implants have a body diameter of 4.0 mm that tapers to approximately 2.3 mm at the apex. The implants have a Morse taper ("CM") abutment interface connection, with an internal 16° cone taper. The abutment platform is 4.0 mm. All implants are threaded starting at the apex and extending approximately 17 mm in the coronal direction, with a major thread diameter of 4 mm; the thread tapers over the final 6 mm of the implant to the apex. The implants are provided with overall lengths of 30, 32.5. 35. 37.5. 40. 42.5.45. 47.5. 50. 52.5.57.5. and 60 mm. The surface of all subject device implants is acid-etched from the implant platform to the apex, followed by application of a hydroxyapatite coating (HA nano).
The subject device abutments are multi-unit, indexed abutments for use only with the subject device Zygomatic Plus Morse Taper implants for maxillary full-arch restorations. The subject device abutments have a prosthetic platform diameter of 4.8 mm, and gingival heights of 1.5, 2.0, and 2.5 mm. The prosthetic post is angled 52° or 60° to the long axis of the implant. These components are used with previously cleared abutment screws.
All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67. All implants have an acid-etched HA100 surface treatment, identical to that cleared in K231127. All subject device abutments are manufactured from titanium alloy (Ti-6A1-4V) conforming to ASTM F136. All subject device implants and abutments are provided sterile to the end user.
The provided text is a 510(k) Summary for a dental implant system. It explicitly states that no clinical data were included in this submission to support substantial equivalence (see "No clinical data were included in this submission." on page 6 of 9).
Therefore, it is not possible to provide specific details about acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, or MRMC studies, as这些 types of studies were not conducted or reported in this 510(k) submission.
The "Performance Data" section (pages 6-7 of 9) refers to non-clinical data only:
- mechanical testing
- gamma irradiation sterilization
- bacterial endotoxin testing
- MR environment evaluation
- sterile barrier shelf life data
- biocompatibility data
These tests are typically conducted to assess the physical and biological characteristics of the device, not its clinical performance in patients as would be measured in an AI/MRMC study.
In summary, based on the provided document, no study was conducted to prove the device meets acceptance criteria related to AI/MRMC performance as outlined in your request. The submission relies on substantial equivalence to predicate devices, supported by non-clinical performance data.
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S.I.N. - Sistema de Implante Nacional S.A. % Kevin Thomas VP & Director of Regulatory Affairs PaxMed International, LLC 12264 EL Camino Real, Suite 400 San Diego, California 92130
July 17, 2024
Re: K240609
Trade/Device Name: S.I.N. Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Product Code: DZE, NHA Dated: March 4, 2024 Received: June 20, 2024
Dear Kevin Thomas:
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).
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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 OS 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.
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3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
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Indications for Use
Submission Number (if known)
Device Name
S.I.N. Dental Implant System
Indications for Use (Describe)
S.I.N. Dental Implant System Zygomatic implants are intended for placement in the maxillary arch to provide support for fixed or removable dental prostheses in patients with partially or fully edentulous maxillae. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System Zygomatic implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K240609 S.I.N. - Sistema de Implante Nacional S.A. S.I.N Dental Implant System
July 17, 2024
ADMINISTRATIVE INFORMATION
| Manufacturer Name | S.I.N. - Sistema de Implante Nacional S.A. | ||
|---|---|---|---|
| Avenida Vereador Abel Ferreira, 1100 | |||
| São Paulo, São Paulo | |||
| 03340-000 Brazil | |||
| Telephone | +55-11-21693000 ext 3236 | ||
| Official Contact | Denise Domiciano, Quality and Regulatory Manager | ||
| Representative/Consultant | Kevin A. Thomas, PhD | ||
| Floyd G. Larson, MS, MBA | |||
| PaxMed International, LLC | |||
| 12264 El Camino Real, Suite 400 | |||
| San Diego, CA 92130 | |||
| Telephone | +1 858-792-1235 | ||
| Fax | +1 858-792-1236 | ||
| kthomas@paxmed.com | |||
| flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | S.I.N. Dental Implant System |
|---|---|
| Common Names | Dental implant |
| Regulation Number | 21 CFR 872.3640 |
| Regulation Name | Endosseous dental implant |
| Regulatory Class | Class II |
| Product Code | DZE |
| Secondary Product Code | NHA |
| Classification Panel | Dental |
| Reviewing Office | Office of Health Technology 1 (Ophthalmic, Anesthesia, Respiratory,ENT and Dental Devices) |
| Reviewing Division | Division of Dental and ENT Devices |
PREDICATE DEVICE INFORMATION
Primary Predicate Device K231127, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A.
Reference Devices K161598, NobelZygoma 0°, Nobel Biocare AB
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K190718, Zygomatic Implants, JJGC Indústria e Comércio de Materiais Dentários S.A. K203542, Neodent Implant System - Mini Abutment 60°, JJGC Indústria e Comércio de Materiais Dentários S.A.
INDICATIONS FOR USE STATEMENT
S.I.N. Dental Implant System Zygomatic implants are intended for placement in the maxillary arch to provide support for fixed or removable dental prostheses in patially or fully edentulous maxillae. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System Zygomatic implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
SUBJECT DEVICE DESCRIPTION
The purpose of this submission is to add components to the S.I.N. Dental Implant System. This submission includes zygomatic dental implants and mating abutments for screw-retained, multi-unit prostheses.
The subject device Zygomatic Plus Morse Taper implants have a body diameter of 4.0 mm that tapers to approximately 2.3 mm at the apex. The implants have a Morse taper ("CM") abutment interface connection, with an internal 16° cone taper. The abutment platform is 4.0 mm. All implants are threaded starting at the apex and extending approximately 17 mm in the coronal direction, with a major thread diameter of 4 mm; the thread tapers over the final 6 mm of the implant to the apex. The implants are provided with overall lengths of 30, 32.5. 35. 37.5. 40. 42.5.45. 47.5. 50. 52.5.57.5. and 60 mm. The surface of all subject device implants is acid-etched from the implant platform to the apex, followed by application of a hydroxyapatite coating (HA nano).
The subject device abutments are multi-unit, indexed abutments for use only with the subject device Zygomatic Plus Morse Taper implants for maxillary full-arch restorations. The subject device abutments have a prosthetic platform diameter of 4.8 mm, and gingival heights of 1.5, 2.0, and 2.5 mm. The prosthetic post is angled 52° or 60° to the long axis of the implant. These components are used with previously cleared abutment screws.
All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67. All implants have an acid-etched HA100 surface treatment, identical to that cleared in K231127. All subject device abutments are manufactured from titanium alloy (Ti-6A1-4V) conforming to ASTM F136. All subject device implants and abutments are provided sterile to the end user.
PERFORMANCE DATA
Non-clinical data provided in this submission in support of substantial equivalence included:
- mechanical testing conducted using a method modified from ISO 14801 and engineering analysis to demonstrate that the subject device implants, in combination with the subject device abutments have sufficient strength for the intended use.
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Non-clinical data referenced from prior submissions in support of substantial equivalence included:
- referenced from K231127, gamma irradiation sterilization for all subject devices to a sterility . assurance level of 10 by selecting and substantiating a 25 kGy dose using method VDmass according to ISO 11137-1 and ISO 11137-2:
- . referenced from K231127, bacterial endotoxin testing including Limulus amebocyte lysate (LAL) test according to ANSI/AAMI ST72 on samples of water used in manufacturing on a weekly basis and on samples from sterilized product on a quarterly basis to demonstrate all sterile product meets a limit of < 20 EU/device;
- referenced from K231127 (provided in K222231), non-clinical analysis and testing to evaluate the . metallic subject devices and compatible dental implants in the MR environment according to ASTM F2052 (magnetically induced displacement force), ASTM F2213 (magnetically induced torque), ASTM F2182 (RF induced heating), and ASTM F2119 (image artifact), and the FDA guidance document Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (issued May 2021);
- referenced from K231127 (provided in K203725), sterile barrier shelf life data; and ●
- . referenced from K231127 (provided in K200992), biocompatibility data for the subject device materials (ASTM F67, ASTM F136), and the implant surface treatment (acid-etched and HA™ coating).
No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICES
The subject device is substantially equivalent in indications and design principles to the primary predicate device and the reference device listed above. Provided at the end of this summary is a table comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device, and the reference device.
The primary predicate device K231127 is in support of substantial equivalence of the Indications for Use, implant designs, abutment designs, materials, manufacturing, sterilization, and shelf life. The reference device K161598 is in support of substantial equivalence of the abutment design with an angulation of 60°.
The Indications for Use Statement (IFUS) for the subject device is identical to that of the primary predicate device K231127. The IFUS for the subject device is similar to the IFUS of the reference device K161598, including language referring to placement in the upper jaw arch/zygoma, and language concerning immediate loading.
The subject device zygomatic implants are substantially equivalents in the primary predicate device K231127 in terms of the Morse taper connection, body diameter, and the range of implant lengths. The subject device zygomatic implants have a more rounded, smoother apex as compared to the zygomatic implants in K231127. The subject device zygomatic implants are manufactured from unalloyed titanium conforming to ASTM F67 that is identical to that used for the implants cleared in the primary predicate device K231127. The subject device implants have an endosseous surface (acid-etched and HA1000 coating) that also is identical to that of the primary predicate device K231127.
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510(k) Summary Page 4 of 6
The subject device abutments are identical to the abutments cleared in the primary predicate device K231127 in terms of the material (Ti-6Al-4V alloy conforming to ASTM F136), anodization, Morse taper connection, implant-abutment platform, and prosthetic platform. The subject device abutments are substantially equivalent to the abutments cleared in the reference device K161598 in terms of the maximum angulation (subject device abutments have angulation of 52° or 60°, and abutments cleared in K161598 have angulation of 45° or 60°).
The subject device implants, implant cover screws, and abutments are provided sterile to the end user by means of gamma irradiation; this is the same sterilization method as used for the primary predicate device K231127. The subject device zygomatic implants are packaged in the same way as the zygomatic implants in the primary predicate device K231127. All subject device components are packaged in a polyethylene terephthalate blister pack with a Tyvek cover and the appropriate label. This is the same packaging used for the primary predicate device K231127.
The risks associated with the subject device abutment designs are mitigated by mechanical testing, including comparison testing to constructs of zygomatic implants and abutments from the reference devices K190718 and K203542, respectively, and an engineering rationale demonstrating that the subject device implants in combination with the subject device angled abutments have sufficient strength for their intended use.
CONCLUSION
The subject device, the primary predicate device, and the reference device have the same intended use, have similar technological characteristics, and are made of identical or similar materials. The subject device, the primary predicate, and the reference device encompass the same range of physical dimensions, are packaged in similar materials, and are sterilized using similar methods.
The data included in this submission demonstrate substantial equivalence to the primary predicate device and the reference device listed above.
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| Subject Device | Predicate Device | Reference Device | Reference Device | Reference Device | |
|---|---|---|---|---|---|
| K240609S.I.N. Dental Implant System | K231127S.I.N. Dental Implant System | K161598NobelZygoma 0° | K190718Zygomatic Implants | K203542Neodent Implant System - MiniAbutment 60° | |
| S.I.N. - Sistema de Implante Nacional S.A. | S.I.N. - Sistema de Implante Nacional S.A. | Nobel Biocare AB | JJGC Indústria e Comércio de MateriaisDentários S.A. | JJGC Indústria e Comércio de MateriaisDentários S.A. | |
| Indications for Use Statement | S.I.N. Dental Implant System Zygomaticimplants are intended for placement in themaxillary arch to provide support for fixed orremovable dental prostheses in patients withpartially or fully edentulous maxillae. When aone-stage surgical approach is applied, theS.I.N. Dental Implant System Zygomaticimplants are intended for immediate loadingwhen good primary stability is achieved andwith appropriate occlusal loading. | S.I.N. Dental Implant System Zygomaticimplants are intended for placement in themaxillary arch to provide support for fixed orremovable dental prostheses in patients withpartially or fully edentulous maxillae. When aone-stage surgical approach is applied,the S.I.N. Dental Implant System Zygomaticimplants are intended for immediate loadingwhen good primary stability is achieved andwith appropriate occlusal loading. | NobelZygoma implants are endosseous dentalimplants intended to be surgically placed inthe bone of the upper jaw arch to providesupport for prosthetic devices, such asartificial teeth, in order to restore patientesthetics and chewing function. TheNobelZygoma Implants are appropriate forimmediate loading when good primarystability is achieved and with appropriateocclusal loading. | Zygomatic Implants are indicated for surgicalinstallation in the zygoma region, in cases ofsevere jaw resorption, in order to restorepatient esthetics and chewing function.Zygomatic Implants are recommended for theposterior (pre-molar/molar) region, oneimplant on each side, with at least twostandard dental implants in the anterior regionto support a fixed restoration. ZygomaticImplants may be loaded immediately whengood primary stability is achieved and withappropriate occlusal loading. | The Mini Conical Abutments are indicatedfor use with Zygomatic Implants, in cases ofsevere jaw resorption, in order to restorepatient aesthetics and chewing function. Itmay be used with single-stage or two-stageprocedures, for multiple unit restorations, andmay be loaded immediately when goodprimary stability is achieved and withappropriate occlusal loading. |
| Reason for Predicate /Reference Devices | Not applicable | Indications for Use Statement; implantdesign; abutment design; materials;sterilization; shelf life | Abutment design, angulation of 60° | Implant design;used in comparative mechanical testing | Abutment design;used in comparative mechanical testing |
| Product Codes | DZE, NHA | DZE, NHA | DZE, NHA | DZE, NHA | NHA |
| Intended Use | Functional and esthetic rehabilitation of theedentulous maxilla | Functional and esthetic rehabilitation of theedentulous maxilla | Functional and esthetic rehabilitation of theedentulous maxilla | Functional and esthetic rehabilitation of theedentulous maxilla | Functional and esthetic rehabilitation of theedentulous maxilla |
| Implant Designs | |||||
| Implant type | Zygomatic | Zygomatic | Zygomatic | Zygomatic | Not applicable |
| Marketing Name | Implant Zygomatic Morse Taper Plus | Implant Zygomatic Plus Morse Taper | NobelZygoma 0° | Zygomatic Implants | Not applicable |
| Prosthetic InterfaceConnections | Morse taper, 16° | Morse taper, 16° | External hex | Morse taper, 16° (GM, Grand Morse) | Morse taper, 16° (GM, Grand Morse) |
| Body Diameter | 4.0 mm (full length) | 4.0 mm (full length) | 4.5 mm (coronal), taper to 4.3 mm (middle)to 5.0 mm (apical) | 4.0 mm (full length) | Not applicable |
| Platform Diameter | 4.0 mm | 4.0 mm | 4.5 mm | 4.0 mm | Not applicable |
| Platform-to-Implant AxisAngle | 0°(Platform orthogonal to implant long axis) | 0°(Platform orthogonal to implant long axis) | 0°(Platform orthogonal to implant long axis) | 0°(Platform orthogonal to implant long axis) | Not applicable |
| Lengths | 30 mm – 60 mm2.5 mm increments | 30 mm – 60 mm2.5 mm increments | 30 mm - 50 mm | 30 mm - 55 mm | Not applicable |
| Thread Diameter andThreaded Length | Thread diameter: 4.0 mmThread length: 17 mm, starts at apex extendscoronally | Thread diameter: 4.0 mmThread length: 17 mm, starts at apex extendscoronally | Not stated in 510(k) Summary | Not stated in 510(k) Summary | Not applicable |
| Implant Material | Unalloyed titanium, ASTM F67 | Unalloyed titanium, ASTM F67 | Unalloyed titanium, ASTM F67 | Unalloyed titanium, ASTM F67 | Not applicable |
| Implant Endosseous Surface | Acid-etched and HAnano | Acid-etched and HAnano | TiUnite | Sand blasted, acid etched (NeoPoros) | Not applicable |
| Abutments | |||||
| Abutment designs | Abutment Mini Angled Morse Taper 52°, 60°Platform Ø: 4.1 mmProsthetic Platform Ø: 4.8 mmGingival Height: 1.5, 2, 2.5 mmAngulation: 52°, 60° | Abutment Mini Angled Morse Taper 45°Platform Ø: 4.1 mmProsthetic Platform Ø: 4.8 mmGingival Height: 2 mm and 3 mmAngulation: 45° | NobelZygoma 0° AbutmentsPlatform: Nobel Ex Hex Regular (RP)Prosthetic Platform: Not stated in 510(k)SummaryGingival Height: 6, 8, 10 mmAngulation: 45°, 60° | Zygomatic AbutmentsPlatform: Neodent GMProsthetic Platform: Not stated in 510(k)SummaryGingival Height: 1.5, 2.5 mmAngulation: 45° | Mini Abutment 60°Platform: Neodent GMProsthetic Platform: Not stated in 510(k)SummaryGingival Height: 1.5, 2.5 mmAngulation: 60° |
| Prosthesis Attachment | Screw-retained, multi-unit | Screw-retained, multi-unit | Screw-retained, multi-unit | Screw-retained, multi-unit | Screw-retained, multi-unit |
| Abutment Material | Titanium alloy, ASTM F136 | Titanium alloy, ASTM F136 | Titanium alloy, ASTM F136 | Titanium alloy, Ti-6Al-4V | Titanium alloy, ASTM F136 |
| Abutment Screw Material | Titanium alloy, ASTM F136 | Titanium alloy, ASTM F136 | Titanium alloy, ASTM F136 | Not stated in 510(k) Summary | Not stated in 510(k) Summary |
Table of Substantial Equivalence
| Implant Endosseous Surface | Acid-etched and HAnano | Acid-etched and HAnano | TiUnite | Sand blasted, acid etched (N/A) |
|---|---|---|---|---|
| Abutments | ||||
| Abutment designs | Abutment Mini Angled Morse Taper 52°, 60°Platform Ø: 4.1 mmProsthetic Platform Ø: 4.8 mmGingival Height: 1.5, 2, 2.5 mmAngulation: 52°, 60° | Abutment Mini Angled Morse Taper 45°Platform Ø: 4.1 mmProsthetic Platform Ø: 4.8 mmGingival Height: 2 mm and 3 mmAngulation: 45° | NobelZygoma 0° AbutmentsPlatform: Nobel Ex Hex Regular (RP)Prosthetic Platform: Not stated in 510(k)SummaryGingival Height: 6, 8, 10 mmAngulation: 45°, 60° | Zygomatic AbutmentsPlatform: Neodent GMProsthetic Platform: Not stated in 510(k)SummaryGingival Height: 1.5, 2.5 mmAngulation: 45° |
| Prosthesis Attachment | Screw-retained, multi-unit | Screw-retained, multi-unit | Screw-retained, multi-unit | Screw-retained, multi-unit |
| Abutment Material | Titanium alloy, ASTM F136 | Titanium alloy, ASTM F136 | Titanium alloy, ASTM F136 | Titanium alloy, Ti-6Al-4V |
| Abutment Screw Material | Titanium alloy, ASTM F136 | Titanium alloy, ASTM F136 | Titanium alloy, ASTM F136 | Not stated in 510(k) Summary |
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| Subject Device | Predicate Device | Reference Device | Reference Device | Reference Device | |
|---|---|---|---|---|---|
| K240609 | K231127 | K161598 | K190718 | K203542 | |
| S.I.N. Dental Implant System | S.I.N. Dental Implant System | NobelZygoma 0° | Zygomatic Implants | Neodent Implant System - Mini | |
| S.I.N. - Sistema de Implante Nacional S.A. | S.I.N. - Sistema de Implante Nacional S.A. | Nobel Biocare AB | JJGC Indústria e Comércio de MateriaisDentários S.A. | Abutment 60°JJGC Indústria e Comércio de MateriaisDentários S.A. | |
| How Provided | |||||
| Implants, Implant Cover Screw | All sterile by gamma irradiation | All sterile by gamma irradiation | All sterile by gamma irradiation | All sterile by gamma irradiation | Not applicable |
| Abutments | All sterile by gamma irradiation | All sterile by gamma irradiation | All sterile by gamma irradiation | All sterile by ethylene oxide | All sterile by ethylene oxide |
| Abutment Screws | All sterile by gamma irradiation(Screws were previously cleared) | All sterile by gamma irradiation | All sterile by gamma irradiation | Not stated in 510(k) Summary | Not stated in 510(k) Summary |
§ 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.