(231 days)
No
The 510(k) summary describes a physical dental implant system and its components. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The referenced image processing relates to MR compatibility testing, not AI/ML-based image analysis for diagnosis or treatment planning.
Yes
The device is a dental implant system intended to provide support for fixed or removable dental prostheses, which directly addresses a medical condition (edentulous maxillae) and restores function, thus classifying it as therapeutic.
No
Explanation: The device is a dental implant system used for supporting dental prostheses, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (zygomatic dental implants, abutments, screws) made of titanium and titanium alloy, which are hardware. The submission also includes non-clinical testing for mechanical strength and MR compatibility, which are relevant to hardware performance.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "placement in the maxillary arch to provide support for fixed or removable dental prostheses." This describes a surgical implant used directly in the body for structural support.
- Device Description: The description details the physical characteristics of dental implants, abutments, and screws made of titanium. These are physical components intended for implantation.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such testing on bodily specimens.
- Lack of IVD Characteristics: There is no mention of reagents, calibrators, controls, or any other components typically associated with in vitro diagnostic testing. The performance studies focus on mechanical strength, sterilization, and MR compatibility, not diagnostic accuracy.
Therefore, this device falls under the category of a surgical implant or dental device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
DZE, NHA
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, mating abutments for screw-retained, multi-unit prostheses, and the corresponding abutment screws.
The subject device Zygomatic Plus Morse Taper implants have a body diameter of 4.0 mm that tapers to 1.65 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 2 mm and 3 mm. The prosthetic post is angled 45° to the long axis of the implant. These components are used with subject device abutment and prosthetic screws, or previously cleared screws.
All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67. All implants have an acid-etched HA1200 surface treatment, identical to that cleared in K200992. All subject device abutments are manufactured from titanium alloy (Ti-6A1-4V) conforming to ASTM F136. All subject device implants, abutments, and abutment screws are provided sterile to the end user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Maxillary arch
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)
Non-clinical data provided in this submission in support of substantial equivalence included:
- gamma irradiation sterilization validation for all subject devices to a sterility assurance level of 10° by . selecting and substantiating a 25 kGy dose using method VDmax25according to ISO 11137-1 and ISO 11137-2; and
- mechanical testing conducted using a method modified from ISO 14801 and engineering analysis to ● demonstrate that the subject device abutments, in combination with the subject device abutments have sufficient strength for the intended use.
Non-clinical data referenced from prior submissions in support of substantial equivalence included:
- . referenced from 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 K203725, sterile barrier shelf life data; and ●
- . referenced from K200992, biocompatibility data for the subject device materials (ASTM F67, ASTM F136), and the implant surface treatment (acid-etched and HA"an" coating).
No clinical data were included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K161598, K222497, K190718, K200992
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
S.I.N. - Sistema de Implante Nacional S.A. % Kevin Thomas Vice President & Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
December 7, 2023
Re: K231127
Trade/Device Name: S.I.N. Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 9, 2023 Received: November 9, 2023
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.
1
2
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).
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
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
3
Indications for Use
510(k) Number (if known) K231127
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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4
510(k) Summary K231127 S.I.N. - Sistema de Implante Nacional S.A. S.I.N Dental Implant System
December 4, 2023
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
Email kthomas@paxmed.com
flarson@paxmed.com | | |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | S.I.N. Dental Implant System |
|---|---|
| Common Names | Dental implant abutment |
| 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 K203725, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A.
Reference Devices K161598, NobelZygoma 0°, Nobel Biocare AB
5
K222497, ZAGA Zygomatic System, Southern Implants (Pty) Ltd K190718, Zygomatic Implants, JJGC Indústria e Comércio de Materiais Dentários SA K200992, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional 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 patients with 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, mating abutments for screw-retained, multi-unit prostheses, and the corresponding abutment screws.
The subject device Zygomatic Plus Morse Taper implants have a body diameter of 4.0 mm that tapers to 1.65 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 2 mm and 3 mm. The prosthetic post is angled 45° to the long axis of the implant. These components are used with subject device abutment and prosthetic screws, or previously cleared screws.
All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67. All implants have an acid-etched HA1200 surface treatment, identical to that cleared in K200992. All subject device abutments are manufactured from titanium alloy (Ti-6A1-4V) conforming to ASTM F136. All subject device implants, abutments, and abutment screws are provided sterile to the end user.
PERFORMANCE DATA
Non-clinical data provided in this submission in support of substantial equivalence included:
- gamma irradiation sterilization validation for all subject devices to a sterility assurance level of 10° by . selecting and substantiating a 25 kGy dose using method VDmax25according to ISO 11137-1 and ISO 11137-2; and
- mechanical testing conducted using a method modified from ISO 14801 and engineering analysis to ● demonstrate that the subject device abutments, in combination with the subject device abutments have sufficient strength for the intended use.
6
Non-clinical data referenced from prior submissions in support of substantial equivalence included:
- . referenced from 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 K203725, sterile barrier shelf life data; and ●
- . referenced from K200992, biocompatibility data for the subject device materials (ASTM F67, ASTM F136), and the implant surface treatment (acid-etched and HA"an" 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 devices 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 devices.
The primary predicate device K203725 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 implant design including the platform 90° to long axis of the implant, the surface-treated unthreaded length of the implant (threads start at apex and extend 18 mm coronally), and the use of the implants with abutments with an angulation of 45°. The reference device K222497 is in support of substantial equivalence of the implant lengths of 30 mm to 60 mm. The reference device K190718 is in support of substantial equivalence of the implant body diameter of 4 mm, implant platform diameter of 4.0 mm, and the use of the implants with an angulation of 45°. The reference device K200992 is in support of substantial equivalence of the implant endosseous surface treatment (acid-etched and HA™® coating), and the subject device abutment designs.
The Indications for Use Statement (IFUS) for the subject device is identical to the zygomatic implant portion of the IFUS for the primary predicate device K203725. The IFUS for the primary predicate device K203725 includes language for conventional dental implants that is not applicable to the subject device.
The IFUS for the subject device is similar to the IFUS of the reference devices K161598, K222497, and K190718. The IFUS of these reference devices all refer to placement in the upper jaw arch/zygoma, and all include language concerning immediate loading. The slight differences in language for the subject device IFUS compared to these reference devices do not impact the intended use as zygomatic implants. The IFUS for the reference device K200992 is for conventional implants and is not applicable to the subject device. As stated above, the IFUS of the subject device is identical to the zygomatic implant portion of the IFUS for the primary predicate device K203725.
The subject device zygomatic implants are substantially equivalent to the reference devices in terms of the body diameter and platform diameter (K190718), the range of implant lengths (K222497), and the use of the implants with abutments having an angulation of 45° (K161598 and K190718). The subject device zygomatic implant surface (acid-etched and HA™® coating) is identical to that of the reference device K200992. The subject device abutments are substantially equivalent to abutments cleared in the reference device
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510(k) Summary Page 4 of 6
K200992. The subject device abutments have the same Morse taper interface (16°), prosthetic platform diameter (4.8 mm), and gingival heights (2 mm and 3 mm) as abutments cleared in the reference device K200992. The subject device abutments have a lager angulation (45°) than the abutments cleared in K200992. The risks associated with the subject device abutment designs are mitigated by mechanical testing using a method modified from ISO 14801 and an engineering rationale to demonstrate that the subject device implants in combination with the subject device angled abutments have sufficient strength for their intended use.
The subject device implants, abutment screws 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 K203725 and the reference device K200992. The subject device zygomatic implants are packaged in the same way as the zygomatic implants in the primary predicate device K203725. 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 K203725 and the reference device K200992.
CONCLUSION
The subject device, the primary predicate device, and the reference devices 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 devices 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 devices listed above.
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Table of Substantial Equivalence
| Subject Device | Primary Predicate | Reference Device | Reference Device | Reference Device | Reference Device | |
|---|---|---|---|---|---|---|
| K231127 | K203725 | K161598 | K222497 | K190718 | K200992 | |
| S.I.N. Dental Implant System | S.I.N. Dental Implant System | NobelZygoma 0° | ZAGA Zygomatic System | Zygomatic Implants | S.I.N. Dental Implant System | |
| S.I.N. - Sistema de Implante | ||||||
| Nacional S.A. | S.I.N. - Sistema de Implante | |||||
| Nacional S.A. | Nobel Biocare AB | Southern Implants (Pty) Ltd | JJGC Indústria e Comércio de | |||
| Materiais Dentários SA | S.I.N. - Sistema de Implante | |||||
| Nacional 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 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. | S.I.N. Dental Implant System is | |||||
| intended for placement in the | ||||||
| maxillary or mandibular arch to | ||||||
| provide support for single-unit or | ||||||
| multi-unit restorations. When a one- | ||||||
| stage surgical approach is applied, the | ||||||
| S.I.N. Dental Implant System is | ||||||
| intended for immediate loading when | ||||||
| good primary stability is achieved and | ||||||
| with appropriate occlusal loading. | ||||||
| S.I.N. Dental Implant System implants | ||||||
| with lengths of 18, 20, 22, or 24 mm | ||||||
| when placed in the maxilla are only | ||||||
| indicated for multiple unit restorations | ||||||
| in splinted applications that utilize at | ||||||
| least two implants. | ||||||
| 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. | NobelZygoma implants are | |||||
| endosseous dental implants intended | ||||||
| to be surgically placed in the bone of | ||||||
| the upper jaw arch to provide support | ||||||
| for prosthetic devices, such as | ||||||
| artificial teeth, in order to restore | ||||||
| patient esthetics and chewing function | ||||||
| The NobelZygoma Implants are | ||||||
| appropriate for immediate loading | ||||||
| when good primary stability is | ||||||
| achieved and with appropriate occlusal | ||||||
| loading. | Southern Implants ZAGA Zygomatic | |||||
| System implants are intended to be | ||||||
| implanted in the upper jaw arch to | ||||||
| provide support for fixed dental | ||||||
| prostheses in patients with partially or | ||||||
| fully edentulous maxillae. All | ||||||
| implants are appropriate for immediate | ||||||
| loading when good primary stability is | ||||||
| achieved and with appropriate occlusal | ||||||
| loading. | Zygomatic Implants are indicated for | |||||
| surgical installation in the zygoma | ||||||
| region, in cases of severe jaw | ||||||
| resorption, in order to restore patient | ||||||
| esthetics and chewing function. | ||||||
| Zygomatic Implants are recommended | ||||||
| for the posterior (pre-molar/molar) | ||||||
| region, one implant on each side, with | ||||||
| at least two standard dental implants | ||||||
| in the anterior region to support a | ||||||
| fixed restoration. Zygomatic Implants | ||||||
| may be loaded immediately when | ||||||
| good primary stability is achieved and | ||||||
| with appropriate occlusal loading. | S.I.N. Dental Implant System is | |||||
| intended for placement in the | ||||||
| maxillary or mandibular arch to | ||||||
| provide support for single-unit or | ||||||
| multi-unit restorations. When a one- | ||||||
| stage surgical approach is applied, the | ||||||
| S.I.N. Dental Implant System is | ||||||
| intended for immediate loading when | ||||||
| good primary stability is achieved and | ||||||
| with appropriate occlusal loading. | ||||||
| Reason for Predicate / | ||||||
| Reference Devices | Not applicable | Indications for Use Statement; | ||||
| implant design; abutment design; | ||||||
| materials; sterilization; shelf life | Implant design; | |||||
| abutment design | Implant design | Implant design | Abutment design; | |||
| implant HAnano surface | ||||||
| Product Codes | DZE, NHA | DZE, NHA | DZE, NHA | DZE | DZE, NHA | DZE, NHA |
| Intended Use | Functional and esthetic rehabilitation | |||||
| of the edentulous maxilla | Functional and esthetic rehabilitation | |||||
| of the edentulous mandible or maxilla | Functional and esthetic rehabilitation | |||||
| of the edentulous maxilla | Functional and esthetic rehabilitation | |||||
| of the edentulous maxilla | Functional and esthetic rehabilitation | |||||
| of the edentulous maxilla | Functional and esthetic rehabilitation | |||||
| of the edentulous mandible or maxilla | ||||||
| Implant Designs | ||||||
| Implant type | Zygomatic | Zygomatic | Zygomatic | Zygomatic | Zygomatic | Conventional |
| Prosthetic Interface | ||||||
| Connections | Morse taper, 16° | External hex | External hex | External hex | Morse taper (GM, 16°) | Morse taper, 11.5° |
| Body Diameter | 4.0 mm (full length) | 4.5 mm (coronal) taper to 3.85 mm | ||||
| (apical) | 4.5 mm (coronal), taper to 4.3 mm | |||||
| (middle) to 5.0 mm (apical) | ZAGA round: 4.3 mm (coronal) taper | |||||
| to 3.4 mm (apical) | ||||||
| ZAFA flat: 4.3 mm (coronal with 3.35 | ||||||
| mm flat) taper to 3.4 mm (apical) | 4.0 mm (full length) | Various implant body/platform | ||||
| diameters | ||||||
| 3.5/3.5 mm to 5.0/5.0 mm | ||||||
| Platform Diameter | 4.0 mm | 4.1 mm | 4.5 mm | 4.07 mm | 4.0 mm | |
| Subject Device | Primary Predicate | Reference Device | Reference Device | Reference Device | Reference Device | |
| K231127 | ||||||
| S.I.N. Dental Implant System | K203725 | |||||
| S.I.N. Dental Implant System | K161598 | |||||
| NobelZygoma 0° | K222497 | |||||
| ZAGA Zygomatic System | K190718 | |||||
| Zygomatic Implants | K200992 | |||||
| S.I.N. Dental Implant System | ||||||
| S.I.N. - Sistema de Implante | ||||||
| Nacional S.A. | S.I.N. - Sistema de Implante | |||||
| Nacional S.A. | Nobel Biocare AB | Southern Implants (Pty) Ltd | JJGC Indústria e Comércio de | |||
| Materiais Dentários SA | S.I.N. - Sistema de Implante | |||||
| Nacional S.A. | ||||||
| Platform-to-Implant | ||||||
| Axis Angle | 0° | |||||
| (Platform 90° to implant long axis) | 45° | 0° | ||||
| (Platform 90° to implant long axis) | 55° | 0° | ||||
| (Platform 90° to implant long axis) | 0° | |||||
| (Platform 90° to implant long axis) | ||||||
| Lengths | 30 mm - 60 mm | |||||
| 2.5 mm increments | 34 mm – 59 mm | 30 mm - 50 mm | ZAGA Round: 30, 32.5, 57.5, 60 mm | |||
| ZAGA Flat: 55, 57.5, 60 mm | 30 mm - 55 mm | 8.5 mm - 15 mm | ||||
| Thread Diameter and | ||||||
| Threaded Length | Thread diameter: 4.0 mm | |||||
| Thread length: 17 mm, starts at apex | ||||||
| extends coronally | Coronal thread diameter: 4.5 mm | |||||
| Coronal threaded length: 2.15 mm | ||||||
| Apical thread diameter: 3.85 mm | ||||||
| Apical thread length: 10.7 mm | Thread diameter: not stated in 510(k) | |||||
| Summary | ||||||
| Thread length: 18 mm, starts at apex | ||||||
| extends coronally | Not stated in 510(k) Summary | Not stated in 510(k) Summary | Various thread diameters; | |||
| All implants fully threaded | ||||||
| Implant Material | Unalloyed titanium, ASTM F67 | Unalloyed titanium, ASTM F67 | Unalloyed titanium, ASTM F67 | Unalloyed titanium, ASTM F67 | Unalloyed titanium, ASTM F67 | Unalloyed titanium, ASTM F67 |
| Implant Endosseous Surface | Acid-etched and HAnano | Acid-etched | TiUnite | Grit-blasted | NeoPoros | |
| (Grit-blasted and acid-etched) | Acid-etched only and | |||||
| Acid-etched and HAnano | ||||||
| Abutments | ||||||
| Abutment designs | Abutment Mini Angled Morse | |||||
| Taper 45° | ||||||
| Platform Ø: 4.1 mm | ||||||
| Prosthetic Platform Ø: 4.8 mm | ||||||
| Gingival Height: 2 mm and 3 mm | ||||||
| Angulation: 45° | Mini Abutment Zygomatic | |||||
| Standard | ||||||
| Platform Ø: 4.1 mm | ||||||
| Prosthetic Platform Ø: 4.5 mm | ||||||
| Gingival Heights: 3, 4, 5.5 mm | ||||||
| Angulation: 0° (straight) | NobelZygoma 0° Abutments | |||||
| Platform: Nobel Ex Hex Regular (RP) | ||||||
| Prosthetic Platform: Not stated in | ||||||
| 510(k) Summary | ||||||
| Gingival Height: 6, 8, ,10 mm | ||||||
| Angulation: 45°, 60° | 45° angled abutments made of | |||||
| titanium alloy, intended exclusively | ||||||
| for use with the GM Zygomatic | ||||||
| implants | Various designs including: | |||||
| Abutment Mini Angled Morse | ||||||
| Morse taper interface 16° | ||||||
| Prosthetic platform Ø: 4.8 mm | ||||||
| Gingival height: 2, 3, 4 mm | ||||||
| Angulation: 17°, 30° | ||||||
| Mini Abutment Zygomatic Conical | ||||||
| Platform Ø: 4.1 mm | ||||||
| Prosthetic Platform Ø: 4.8 mm | ||||||
| Gingival heights: 2, 3, 4 mm | ||||||
| Straight | ||||||
| Prosthesis Attachment | Screw-retained, multi-unit | Screw-retained, multi-unit | Screw-retained, multi-unit | Screw-retained, multi-unit | Screw-retained, multi-unit | Screw-retained, multi-unit |
| Cement-retained single-unit | ||||||
| Abutment Material | Titanium alloy, ASTM F136 | Titanium alloy, ASTM F136 | Titanium alloy, ASTM F136 | Not stated in 510(k) Summary | Titanium alloy | 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 | Titanium alloy, ASTM F136 |
| How Provided | ||||||
| Implants | All sterile by gamma irradiation | All sterile by gamma irradiation | All sterile by gamma irradiation | All sterile by gamma irradiation | All sterile by gamma irradiation | All sterile by gamma irradiation |
| Abutments, Implant Cover | All sterile by gamma irradiation | All sterile by gamma irradiation | All sterile by gamma irradiation | Not applicable (not in submission) | All sterile by ethylene oxide exposure | All sterile by gamma irradiation |
| Abutment Screws | All sterile by gamma irradiation | All sterile by gamma irradiation | All sterile by gamma irradiation | Not applicable (not in submission) | Not stated in 510(k) Summary | All sterile by gamma irradiation |
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