(110 days)
No
The document describes standard dental implants and abutments made of titanium, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are bench tests and clinical literature reviews, not AI/ML model validation.
Yes
The devices (zygomatic implants, abutments, and coping) are intended to restore chewing function and aesthetics by providing support for prosthetic devices, which are therapeutic goals.
No.
The device descriptions and indications for use clarify that these are implants and prosthetic components for restoring chewing function and aesthetics, not for diagnosing medical conditions.
No
The device description clearly states the devices are physical implants, abutments, and copings made of titanium, provided sterile, and intended for surgical placement. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The descriptions clearly state that these devices are implants, abutments, and copings intended for surgical placement within the body (zygoma region, upper or lower jaw) to restore chewing function and aesthetics by supporting prosthetic devices. They are physical components implanted into the patient.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient. The devices are used directly in the surgical procedure and remain in the body.
Therefore, these devices fall under the category of implantable medical devices rather than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Indications for Use for Zygoma-S GM Implant:
Zygomatic implants are indicated for intraoral surgical procedures in the zygoma region in cases of severe maxilla bone resorption, to restore the patient's chewing function and aesthetics. Zygomatic Implants may be used in one or two-stage procedures, multiple unit restorations, and immediate loading when there is primary stability and adequate occlusal load.
Indications for Use for GM Mini Conical Abutment 52° and 45°:
Product indicated for surgical procedures in zygomatic bones, making possible the rehabilitation with screw-retained abutments over the implant, thus restoring the chewing function. It may be used in one- or two-stage procedures, multiple unit restorations, and immediate loading when there is primary stability and adequate occlusal load. Multiple rehabilitations may be splinted rigidly.
Indications for Use for Coping for Removable Prosthesis:
The product, when used with non-zygomatic implants, 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 multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with approprate occlusal loading. Multiple tooth applications may be rigidly splinted. When used with zygomatic implants, the product is indicated for surgical procedure only in upper jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used in two-stage procedures (delayed loading protocol) and for multiple unit restorations. Multiple rehabilitations may be splinted rigidly.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The subject devices implants are single use devices, provided sterile by Gamma Radiation, made of commercially pure Titanium grade 4 (ASTM F67). The Zygomatic Implant is a long implant with a nominal diameter of 3.50 and 3.75mm, conical apex with rounded tip, 3 helical chambers, trapezoidal thread and GM prosthetic interface. The cervical portion in both models has Ø 4.3 mm. The length varies from 30 to 55 mm. Zygomatic Implants are intended to provide support for a fixed prosthesis in patients with severe atrophy in the maxillary region. They are extra-long to allow bone anchorage in the zygomatic bone. The subject implants consider the Zygoma Anatomy-Guided approach (ZAGA) for planning the surgical steps, being indicated for extrasinus and extra maxillary installation technique (ZAGA-4).
The subject abutments are single use devices, provided sterile by Ethylene Oxide, made of Titanium alloy (Tl6Al4V-ELI). They are intermediate prosthetic components angled at 52 and 45 degrees with gingiva heights 1.5 and 2.5 mm, to be installed on the implant, offering a structure to support the screw-retained multiple prosthesis. The abutments present GM prosthetic interface and are available in the anti-rotational form in the implant to abutment interface, and rotational form in the abutment to prosthesis interface, presenting different transmucosal heights.
The subject coping is single use device, provided sterile by Ethylene Oxide, made of titanium alloy (Ti6Al4V-ELI). It presents a NEO torque interface for torque application. The subject device has diameter 4.80 mm and total height 4.60 mm. They are indicated for removable prostheses with fitting over Mini Conical Abutment installed in the maxilla or mandible and can be used in partial removable prostheses or over dentures. They are compatible with all previously cleared GM Mini Conical abutments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
zygoma region, 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)
Performance Testing – Bench
Dynamic fatigue testing was conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801 "Dentistry — Implants — Dynamic loading test for endosseous dental implants". To comply with the indication for use in ZAGA-4, a deviation in the test configuration was made to better simulate the conditions of use of the devices, being the samples fixation adapted. The test was conducted in a dry environment (15 Hz and 20 ± 5℃) at 5 million cycles covering permanent restoration without implant failure. Results demonstrated the subject devices are equivalent to the reference devices being in compliance with the proposed indication for use.
Insertion tests were performed for the subject implants and it could be proven that there is an adequate insertion torque in different bone classes when the implant is inserted according to the surgical procedure. Torsion Test was also performed to evaluate the strength of the subject device against maximum twisting forces when a rotational loading is applied. The results met the acceptance criteria.
The subject devices were also analyzed using scanning electron microscopy and light microscopy to investigate the apical end of the implant body after removal from the packaging. All the inspected implants showed a uniform breaking surface, with no residual metal fragments at the broken tip area.
Surface treatment
The subject implants have a rough surface in their apical region created by a sand-blasted and acidetched treatment (Neoporos). This surface treatment is equivalent for all Neodent Implants with Neoporos surface, including the primary predicate device. The main difference in the surface treatment of the subject implants is in the cervical portion, which have a smooth machined surface since it does not receive any treatment, similar to the one presented in the reference device (K151909)
MR Compatibility testing
The MR compatibility was performed to access the risk of exposing patients who have implantable medical devices. An assessment was made to demonstrate that the subject devices are MR conditional devices and a patient treated with them can be safely scanned observing the parameters previously established per reference devices.
Sterilization validation
The subject implants are sterilized by Gamma Irradiation, according to ISO 11137-1 and ISO 11137-2, and the subject abutments by Ethylene Oxide, according to ISO 11135-1 via the over-kill method. A minimum Sterility Assurance Level (SAL) of 1 x 10 th has been validated for both methods. The subject devices are not represented to be "non-pyrogenic".
Shelf Life validation
The expiration date of the products was determined considering the integrity of the product and the packaging tests after shelf life testing. The types of packaging of the subject devices are identical to the packaging of the primary predicate devices, including the implant packaging model with an apical pin connection. The shelf life for devices provided sterile is 5 years.
Biocompatibility
Representative samples of each of the subject devices was subjected to the following:
- Biocompatibility sample preparation was made according to ISO 10993-12;
- Biological Safety Assessment guided by ISO 10993-1;
- Cytotoxicity testing was performed per ISO 10993-5;
- Chemical characterization was performed per ISO 10993-18.
Clinical data
Clinical data from the published literature showed 971 smooth zygomatic implants marketed for the rehabilitation of 397 patients with severely resorbed maxillae, with high survival rates (93.3% to 100%) up to 11 years of follow-up. Overall, observed adverse events and complications described in the literature were implant failure, fracture of the zygomatic bone, inflammation, periimplantitis, buccal abscess, sinusitis, paresthesia, bone loss, plaque, bleeding, and soft tissue recession, osseointegration failure, prosthesis and abutment fracture, wrong prosthetic rehabilitation, zygomatic bone periostitis, overloading by the prosthetic over structure, oroantral sinus communications, prosthetic screw and abutment loosening, perforation of sinus membrane and cavity, tooth debonding, mucosal fenestration with no inflammation, slight intrusion movement and maxillary sinus opacity. The adverse events mentioned before are events already known for zygomatic implants in general.
Regarding the clinical outcomes of the predicate device, clinical articles from literature presented, in general, a total of 222 patients with 416 implants placed, mean of follow-up up to 41.75 months and survival rates of 93.3% to 100%. Implant loss, postoperative sinusitis, implant fracture, mucositis, paresthesia, zygomatic bone periostitis, inflammation with fistula, oroantral sinus communications, peri-implantitis were observed as complications.
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.
K151909, K203542, K210356, K173902, K182620
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, 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.
JJGC Indústria e Comércio de Materiais Dentários S.A. % Jennifer Jackson Director of Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K232099
Trade/Device Name: Neodent Implant System - GM Zygomatic Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: Class II Product Code: DZE, NHA Dated: October 4, 2023 Received: October 4, 2023
Dear Jennifer Jackson:
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
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
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) K232099
Device Name
Neodent Implant System - GM Zygomatic Implants System
Indications for Use (Describe)
Indications for Use for Zygoma-S GM Implant:
Zygomatic implants are indicated for intraoral surgical procedures in the zygoma region in cases of severe maxilla bone resorption, to restore the patient's chewing function and aesthetics. Zygomatic Implants may be used in one or two-stage procedures, multiple unit restorations, and immediate loading when there is primary stability and adequate occlusal load.
Indications for Use for GM Mini Conical Abutment 52° and 45°:
Product indicated for surgical procedures in zygomatic bones, making possible the rehabilitation with screw-retained abutments over the implant, thus restoring the chewing function. It may be used in one- or two-stage procedures, multiple unit restorations, and immediate loading when there is primary stability and adequate occlusal load. Multiple rehabilitations may be splinted rigidly.
Indications for Use for Coping for Removable Prosthesis:
The product, when used with non-zygomatic implants, 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 multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with approprate occlusal loading. Multiple tooth applications may be rigidly splinted. When used with zygomatic implants, the product is indicated for surgical procedure only in upper jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used in two-stage procedures (delayed loading protocol) and for multiple unit restorations. Multiple rehabilitations may be splinted rigidly.
| 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
ADMINISTRATIVE INFORMATION
| Sponsor | JJGC Indústria e Comércio de Materiais Dentários SA (dba Neodent) |
|---|---|
| Av. Juscelino Kubitschek de Oliveira, 3291 Curitiba, Paraná, Brazil 81270- | |
| 200 | |
| Registration No.: 3008261720 | |
| Owner/Operator No.: 10031702 | |
| Contact Person | Jennifer M. Jackson, MS |
| Senior Director of Regulatory Affairs and Quality, | |
| Straumann USA | |
| E-Mail: jennifer.jackson@straumann.com | |
| Telephone (978) 747-2509 | |
| Date Prepared | October 27, 2023 |
| Preparer / Alternate | |
| Contact | Mariana Hartmann |
| Regulatory Affairs Coordinator | |
| mariana.hartmann@neodent.com | |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/ Proprietary | |
| Name | Neodent Implant System – GM Zygomatic Implant System |
| Common Name | Endosseous dental implant |
| Classification Name | Implant, Endosseous, Root-Form |
| Classification | |
| Regulations | 21 CFR 872.3640, Class II |
| Product Code (s) | Primary: DZE |
| Secondary: NHA | |
| Classification Panel | Dental Products Panel |
Reviewing Branch Dental Devices Branch
5
PREDICATE DEVICE INFORMATION
| Primary Predicate
Device | K190718, Neodent Implant System - Zygomatic Implants and Abutments,
JJGC Indústria e Comércio de Materiais Dentários S.A |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reference Devices | K151909, Noris Medical - Zygomatic Dental Implant System
K203542, Neodent Implant System - Mini Abutment 60°, JJGC Indústria e
Comércio de Materiais Dentários S.A.
K210356 - Noris Medical Dental Implants System, Noris Medical.
K173902, Neodent Implant System - GM Line, JJGC Indústria e Comércio
de Materiais Dentários S.A
K182620, MRI Compatibility for Existing Neodent Implant System, JJGC
Indústria e Comércio de Materiais Dentários S.A |
INDICATIONS FOR USE
Indications for Use for Zygoma-S GM Implant:
Zygomatic implants are indicated for intraoral surgical procedures in the zygoma region in cases of severe maxilla bone resorption, to restore the patient's chewing function and aesthetics. Zygomatic Implants may be used in one or two-stage procedures, multiple unit restorations, and immediate loading when there is primary stability and adequate occlusal load.
Indications for Use for GM Mini Conical Abutment 52° and 45°:
Product indicated for surgical procedures in zygomatic bones, making possible the rehabilitation with screw-retained abutments over the implant, thus restoring function. It may be used in one- or two-stage procedures, multiple unit restorations, and immediate loading when there is primary stability and adequate occlusal load. Multiple rehabilitations may be splinted rigidly.
Indications for Use for Coping for Removable Prosthesis:
The product, when used with non-zygomatic implants, 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 multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.
When used with zygomatic implants, the product is indicated for surgical procedure only in upper jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used in two-stage procedures (delayed loading protocol) and for multiple unit restorations. Multiple rehabilitations may be splinted rigidly.
6
SUBJECT DEVICE DESCRIPTIONS
The subject devices implants are single use devices, provided sterile by Gamma Radiation, made of commercially pure Titanium grade 4 (ASTM F67). The Zygomatic Implant is a long implant with a nominal diameter of 3.50 and 3.75mm, conical apex with rounded tip, 3 helical chambers, trapezoidal thread and GM prosthetic interface. The cervical portion in both models has Ø 4.3 mm. The length varies from 30 to 55 mm. Zygomatic Implants are intended to provide support for a fixed prosthesis in patients with severe atrophy in the maxillary region. They are extra-long to allow bone anchorage in the zygomatic bone. The subject implants consider the Zygoma Anatomy-Guided approach (ZAGA) for planning the surgical steps, being indicated for extrasinus and extra maxillary installation technique (ZAGA-4).
The subject abutments are single use devices, provided sterile by Ethylene Oxide, made of Titanium alloy (Tl6Al4V-ELI). They are intermediate prosthetic components angled at 52 and 45 degrees with gingiva heights 1.5 and 2.5 mm, to be installed on the implant, offering a structure to support the screw-retained multiple prosthesis. The abutments present GM prosthetic interface and are available in the anti-rotational form in the implant to abutment interface, and rotational form in the abutment to prosthesis interface, presenting different transmucosal heights.
The subject coping is single use device, provided sterile by Ethylene Oxide, made of titanium alloy (Ti6Al4V-ELI). It presents a NEO torque interface for torque application. The subject device has diameter 4.80 mm and total height 4.60 mm. They are indicated for removable prostheses with fitting over Mini Conical Abutment installed in the maxilla or mandible and can be used in partial removable prostheses or over dentures. They are compatible with all previously cleared GM Mini Conical abutments.
7
TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE
Table 1 - Technological Characteristic Comparison Table
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | ||
|---|---|---|---|---|---|---|
| Neodent Implant System | ||||||
| JJGC Indústria e Comércio | ||||||
| de Materiais Dentários | ||||||
| S.A. | K190718 | |||||
| Neodent Implant System | ||||||
| JJGC Indústria e Comércio de | ||||||
| Materiais Dentários S.A. | K151909 | |||||
| Zygomatic Dental Implant | ||||||
| System | ||||||
| Noris Medical | K203542 | |||||
| Neodent Implant System - | ||||||
| Mini Abutment 60° | ||||||
| JJGC Indústria e Comércio de | ||||||
| Materiais Dentários S.A. | K173902 | |||||
| Neodent Implant System - | ||||||
| GM Line | ||||||
| JJGC Indústria e Comércio de | ||||||
| Materiais Dentários S.A. | EQUIVALENCE DISCUSSION | |||||
| Indications for | ||||||
| Use | Implants | |||||
| Zygomatic implants are | ||||||
| indicated for intraoral | ||||||
| surgical procedures in the | ||||||
| zygoma region in cases of | ||||||
| severe maxilla bone | ||||||
| resorption, to restore the | ||||||
| patient's chewing function | ||||||
| and aesthetics. Zygomatic | ||||||
| Implants may be used in | ||||||
| one or two-stage | ||||||
| procedures, multiple unit | ||||||
| restorations, and | ||||||
| immediate loading when | ||||||
| there is primary stability | ||||||
| and adequate occlusal | ||||||
| load. | Implants | |||||
| 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. | Implants | |||||
| NORIS Medical Dental | ||||||
| System is intended to replace | ||||||
| missing tooth/teeth in either | ||||||
| jaw for supporting prosthetic | ||||||
| devices that may aid in restoring | ||||||
| the patient's chewing function. | ||||||
| The procedure can be | ||||||
| accomplished in a one-stage or | ||||||
| two-stage surgical operation. All | ||||||
| implants are appropriate for | ||||||
| immediate loading when good | ||||||
| primary stability is achieved and | ||||||
| with appropriate occlusal | ||||||
| loading. | Equivalent | |||||
| The subject devices and the primary | ||||||
| predicate devices have the same | ||||||
| Indications for Use. | ||||||
| There are some slight differences in | ||||||
| wording between the Indications for | ||||||
| Use Statements for the subject | ||||||
| device and the primary predicate | ||||||
| device that do not affect the | ||||||
| intended use. Both devices are | ||||||
| dental implants to be placed in the | ||||||
| zygoma region in cases of severe jaw | ||||||
| resorption, in order to restore | ||||||
| patient esthetics and chewing | ||||||
| function. |
8
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | EQUIVALENCE DISCUSSION | |
|---|---|---|---|---|---|---|
| Neodent Implant System | ||||||
| JJGC Indústria e Comércio | ||||||
| de Materiais Dentários | ||||||
| S.A. | K190718 | |||||
| Neodent Implant System | ||||||
| JJGC Indústria e Comércio de | ||||||
| Materiais Dentários S.A. | K151909 | |||||
| Zygomatic Dental Implant | ||||||
| System | ||||||
| Noris Medical | K203542 | |||||
| Neodent Implant System - | ||||||
| Mini Abutment 60° | ||||||
| JJGC Indústria e Comércio de | ||||||
| Materiais Dentários S.A. | K173902 | |||||
| Neodent Implant System - | ||||||
| GM Line | ||||||
| JJGC Indústria e Comércio de | ||||||
| Materiais Dentários S.A. | EQUIVALENCE DISCUSSION | |||||
| Abutments | ||||||
| Product indicated for | ||||||
| surgical procedures in | ||||||
| zygomatic bones, making | ||||||
| possible the rehabilitation | ||||||
| with screw-retained | ||||||
| abutments over the | ||||||
| implant, thus restoring the | ||||||
| chewing function. It may be | ||||||
| used in one or two-stage | ||||||
| procedures, multiple unit | ||||||
| restorations, and | ||||||
| immediate loading when | ||||||
| there is primary stability | ||||||
| and adequate occlusal | ||||||
| load. Multiple | ||||||
| rehabilitations may be | ||||||
| splinted rigidly. | Abutments | |||||
| The Mini Conical Abutments | ||||||
| are indicated for use with | ||||||
| Zygomatic Implants, in cases | ||||||
| of severe jaw resorption, in | ||||||
| order to restore patient | ||||||
| aesthetics and chewing | ||||||
| function. It may be used with | ||||||
| single-stage or two-stage | ||||||
| procedures, for multiple unit | ||||||
| restorations, and may be | ||||||
| loaded immediately when | ||||||
| good primary stability is | ||||||
| achieved and with appropriate | ||||||
| occlusal loading. | Equivalent | |||||
| The subject devices and the | ||||||
| reference predicate device | ||||||
| (K203542) have the same Indications | ||||||
| for Use for the Abutments. |
The slight differences in wording
between the Indications for Use
statements for the subject
abutments and the reference device
do not affect their intended use of
restore chewing function in multi-
unit restorations placed onto
zygomatic bone. These text
differences does not result in a
change of the risk-based
assessment, since there is no new
risks or modification of existing risks
already identified for both devices. | |
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | EQUIVALENCE DISCUSSION | |
| Neodent Implant System
JJGC Indústria e Comércio
de Materiais Dentários
S.A. | K190718
Neodent Implant System
JJGC Indústria e Comércio de
Materiais Dentários S.A. | K151909
Zygomatic Dental Implant
System
Noris Medical | K203542
Neodent Implant System -
Mini Abutment 60°
JJGC Indústria e Comércio de
Materiais Dentários S.A. | K173902
Neodent Implant System -
GM Line
JJGC Indústria e Comércio de
Materiais Dentários S.A. | | |
| Abutment for removable
Prosthesis (coping):
The product, when used
with non-zygomatic
implants, 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
multiple unit restorations,
and may be loaded
immediately when good
primary stability is
achieved and with
appropriate occlusal
loading. Multiple tooth
applications may be rigidly
splinted.
When used with zygomatic
implants, the product is
indicated for surgical
procedure only in upper
jaw to provide support for
prosthetic devices, such as
artificial teeth, to restore
chewing function. It may be
used in two-stage
procedures (delayed
loading protocol) and for
multiple unit restorations.
Multiple rehabilitations | | | | Abutment for removable
Prosthesis:
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. | Equivalent
The subject devices and the
reference predicate device
(K173902) have the same indications
for use, being used to restore the
chewing function.
Some slight differences in the text
can be observed as the indication for
use of the subject copings is more
specific to the product and does not
correspond to all Neodent Implant
System. This change was made to
better clarify the application of the
product according to the surgical
situation, but is covered by the
general indication for all system
already presented for the reference
predicate device. | |
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | |
| | Neodent Implant System
JJGC Indústria e Comércio
de Materiais Dentários
S.A. | K190718
Neodent Implant System
JJGC Indústria e Comércio de
Materiais Dentários S.A. | K151909
Zygomatic Dental Implant
System
Noris Medical | K203542
Neodent Implant System -
Mini Abutment 60°
JJGC Indústria e Comércio de
Materiais Dentários S.A. | K173902
Neodent Implant System -
GM Line
JJGC Indústria e Comércio de
Materiais Dentários S.A. | EQUIVALENCE DISCUSSION |
| | Implants
Partially threaded root-
form implant in the lower
region to be used with
matching abutments,
made of Commercially
Pure Titanium (Grade 4) | Implants
Threaded root-form implant
to be used with matching
abutments, made of
Commercially Pure Titanium
(Grade 4) | Implants
Partially threaded root-form
implants for placement into the
zygoma. | | | Equivalent
The design of the subject device is
very similar to the reference device
(K151909). Both are partially
threaded implants. The primary
predicate device is manufactured of
the same raw material of the subject
devices. The equivalence of the
subject and reference device was
evaluated by the comparison of
performance in bench tests and is
being further addressed in this
submission. |
| Design | Abutment
45° and 52° angled
abutments made of
titanium alloy,
intended exclusively for
use with the GM
Zygomatic implants.
Gingival Height: 1.5; 2.5 mm
Angulation: 45° and 52° | Abutment
45° angled abutments
made of titanium alloy,
intended exclusively for
use with the GM
Zygomatic implants.
Gingival Height: 1.5; 2.5 mm
Angulation: 45° | Abutment
45° angled abutments made
of titanium alloy. | Abutment
60° angled abutments
made of titanium alloy,
intended for use with the
GM Zygomatic implants.
Gingival Height: 1.5; 2.5 mm
Angulation: 60° | | Equivalent
The subject device gingival heights
are identical to the primary and
reference devices (K203542). The
angulation of 45° is the same to the
primary predicate devices (K190718)
and the angulation of 52° is lower
than the one of the reference
predicate devices (K203542). Since
the worst case configuration is the
bigger angulation for the system,
bench tests are being provided to
prove equivalency between the
subject devices and reference
devices. |
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | EQUIVALENCE DISCUSSION |
| | Neodent Implant System
JJGC Indústria e Comércio
de Materiais Dentários
S.A. | K190718
Neodent Implant System
JJGC Indústria e Comércio de
Materiais Dentários S.A. | K151909
Zygomatic Dental Implant
System
Noris Medical | K203542
Neodent Implant System -
Mini Abutment 60°
JJGC Indústria e Comércio de
Materiais Dentários S.A. | K173902
Neodent Implant System -
GM Line
JJGC Indústria e Comércio de
Materiais Dentários S.A. | |
| | Abutment for removable
Prosthesis (coping):
Cylindrical abutment with
GM interface.
Made of Ti-6Al-4V alloy,
ASTM F136, with TiN
coating. | | | | Abutment for removable
Prosthesis:
Cylindrical abutment with GM
interface.
Made of Ti-6Al-4V alloy, ASTM
F136, with TiN coating. | Identical
The overall design of the subject
device and the reference device
(K173902) are the same. |
| Reusable | No | No | No | No | No | Identical
All subject devices and predicate
devices are indicated for single use
only. |
| Diameter (mm) | Endosseous diameter
3.5 and 3.75
Platform diameter
4.3 | Endosseous diameter
4.0
Platform diameter
4.0 | Endosseous diameter
4.2
Platform diameter
3.75 | | | Equivalent
Although the subject devices
present some differences in the
diameter size when compared to the
primary and reference devices,
bench tests were performed to
show equivalency. |
| Length (mm)
(Implants) | 30; 35; 37.5; 40; 42.5;
45; 47.5; 50; 52.5; 55 | 30; 35; 37.5; 40; 42.5; 47.5;
50; 52.5; 55 | 35; 37.5; 40; 42.5; 47.5; 50; 52.5;
55; 57.5 | | | Equivalent
The subject devices range of lengths
are similar to the primary and
predicate devices lengths. |
| Implant surfaces | Sand blasted, acid
etched NeoPoros
surface in the thread
region and smooth
surface in the middle
and upper regions. | Sand blasted, acid etched
NeoPoros surface. | Partially threaded root-form
implants for placement into the
zygoma with unthread smooth
surface in coronal portion. | | | Equivalent
The subject devices and the
primary predicate devices present
the same implant surfaces
(Neoporos) in the threaded region
The unthread smooth surface in
upper region is equivalent of
reference predicate device
K151909. |
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | |
| | Neodent Implant System
JJGC Indústria e Comércio
de Materiais Dentários
S.A. | K190718
Neodent Implant System
JJGC Indústria e Comércio de
Materiais Dentários S.A. | K151909
Zygomatic Dental Implant
System
Noris Medical | K203542
Neodent Implant System -
Mini Abutment 60°
JJGC Indústria e Comércio de
Materiais Dentários S.A. | K173902
Neodent Implant System –
GM Line
JJGC Indústria e Comércio de
Materiais Dentários S.A. | EQUIVALENCE DISCUSSION |
| | Sterilization
Method | Implants
Gamma Radiation to
an SAL of 1x10-6 | Implants
Gamma Radiation to an SAL
of 1x10-6 | Implants
Gamma irradiation to an SAL of
1x10-6 | | |
| | Abutments
Ethylene Oxide to an
SAL of 1x10-6 | Abutments
Ethylene Oxide to an SAL of
1x10-6 | | Abutments
Ethylene Oxide to an SAL of
1x10-6 | Abutments
Ethylene Oxide to an SAL of 1x10-6 | Identical
The subject devices and the
primary predicate devices preser
the same Sterilization Methods. |
9
10
11
12
13
The subject device and the primary predicate device K190718 have the equivalent Indications for Use statements, similar designs, equivalent lengths, same surface treatment, same sterilization methods and same sterile barrier. The subject devices and the primary predicate device abutments present same range of gingival height, same raw material, same sterilization method and same sterile barrier.
The subject devices and the reference devices (K151909) have equivalent Indications for Use statements and similar design.
The subject abutments have the equivalent indications for use and same overall design as the reference devices (K293542 and 173902). They also present the same sterilization method and raw materials.
Overall, the subject devices are substantially equivalent to the predicate devices as follows:
- equivalent intended use,
- equivalent technological characteristics,
- equivalent design,
- same operating principle,
- · incorporate the same materials, and
- have same packaging and are sterilized using the same materials and processes.
PERFORMANCE DATA
Performance Testing – Bench
Dynamic fatigue testing was conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801 "Dentistry — Implants — Dynamic loading test for endosseous dental implants". To comply with the indication for use in ZAGA-4, a deviation in the test configuration was made to better simulate the conditions of use of the devices, being the samples fixation adapted. The test was conducted in a dry environment (15 Hz and 20 ± 5℃) at 5 million cycles covering permanent restoration without implant failure. Results demonstrated the subject devices are equivalent to the reference devices being in compliance with the proposed indication for use.
Insertion tests were performed for the subject implants and it could be proven that there is an adequate insertion torque in different bone classes when the implant is inserted according to the surgical procedure. Torsion Test was also performed to evaluate the strength of the subject device against maximum twisting forces when a rotational loading is applied. The results met the acceptance criteria.
The subject devices were also analyzed using scanning electron microscopy and light microscopy to investigate the apical end of the implant body after removal from the packaging. All the inspected implants showed a uniform breaking surface, with no residual metal fragments at the broken tip area.
14
Surface treatment
The subject implants have a rough surface in their apical region created by a sand-blasted and acidetched treatment (Neoporos). This surface treatment is equivalent for all Neodent Implants with Neoporos surface, including the primary predicate device. The main difference in the surface treatment of the subject implants is in the cervical portion, which have a smooth machined surface since it does not receive any treatment, similar to the one presented in the reference device (K151909)
MR Compatibility testing
The MR compatibility was performed to access the risk of exposing patients who have implantable medical devices. An assessment was made to demonstrate that the subject devices are MR conditional devices and a patient treated with them can be safely scanned observing the parameters previously established per reference devices.
Sterilization validation
The subject implants are sterilized by Gamma Irradiation, according to ISO 11137-1 and ISO 11137-2, and the subject abutments by Ethylene Oxide, according to ISO 11135-1 via the over-kill method. A minimum Sterility Assurance Level (SAL) of 1 x 10 th has been validated for both methods. The subject devices are not represented to be "non-pyrogenic".
Shelf Life validation
The expiration date of the products was determined considering the integrity of the product and the packaging tests after shelf life testing. The types of packaging of the subject devices are identical to the packaging of the primary predicate devices, including the implant packaging model with an apical pin connection. The shelf life for devices provided sterile is 5 years.
Biocompatibility
Representative samples of each of the subject devices was subjected to the following:
- · Biocompatibility sample preparation was made according to ISO 10993-12;
- · Biological Safety Assessment guided by ISO 10993-1;
- · Cytotoxicity testing was performed per ISO 10993-5;
- · Chemical characterization was performed per ISO 10993-18.
Clinical data
Clinical data from the published literature showed 971 smooth zygomatic implants marketed for the rehabilitation of 397 patients with severely resorbed maxillae, with high survival rates (93.3% to 100%) up to 11 years of follow-up. Overall, observed adverse events and complications described in the literature were implant failure, fracture of the zygomatic bone, inflammation, periimplantitis, buccal abscess, sinusitis, paresthesia, bone loss, plaque, bleeding, and soft tissue recession, osseointegration failure, prosthesis and abutment fracture, wrong prosthetic rehabilitation, zygomatic bone periostitis, overloading by the prosthetic over structure, oroantral sinus communications, prosthetic screw and abutment loosening, perforation of sinus membrane and cavity, tooth debonding, mucosal fenestration with no inflammation, slight intrusion movement and maxillary sinus opacity. The adverse events mentioned before are events already known for zygomatic implants in general.
15
Regarding the clinical outcomes of the predicate device, clinical articles from literature presented, in general, a total of 222 patients with 416 implants placed, mean of follow-up up to 41.75 months and survival rates of 93.3% to 100%. Implant loss, postoperative sinusitis, implant fracture, mucositis, paresthesia, zygomatic bone periostitis, inflammation with fistula, oroantral sinus communications, peri-implantitis were observed as complications.
Therefore, the clinical data evidence that the JJGC Zygoma-S GM Implants are safe and have an suitable performance if used according to the indications for use.
CONCLUSION
The data included in this submission demonstrate that the subject devices are substantially equivalent to the predicate devices in terms of functional and mechanical properties, sterilization method, technological characteristics, design, indications for use and raw material.