Who is the manufacturer of Neodent Implant System - GM Zygomatic Implant System?

JJGC Indústria e Comércio de Materiais Dentários S.A. filed the 510(k) submission for Neodent Implant System - GM Zygomatic Implant System (K232099).

What is the FDA product code for Neodent Implant System - GM Zygomatic Implant System?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Neodent Implant System - GM Zygomatic Implant System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Neodent Implant System - GM Zygomatic Implant System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Neodent Implant System - GM Zygomatic Implant System

K232099 · JJGC Indústria e Comércio de Materiais Dentários S.A. · DZE · Oct 31, 2023 · Dental

Device Facts

Record ID	K232099
Device Name	Neodent Implant System - GM Zygomatic Implant System
Applicant	JJGC Indústria e Comércio de Materiais Dentários S.A.
Product Code	DZE · Dental
Decision Date	Oct 31, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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. 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. 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.

Device Story

Neodent Implant System - GM Zygomatic Implant System consists of endosseous dental implants, angled abutments, and copings. Implants are extra-long (30-55mm) titanium grade 4 devices designed for anchorage in the zygomatic bone to support fixed prostheses in severely atrophic maxillae. Abutments (45°/52°) and copings are titanium alloy (Ti6Al4V-ELI). Used by dental surgeons in clinical settings. Implants utilize ZAGA-4 anatomy-guided installation. Output is a stable foundation for prosthetic teeth. Benefits include restoration of chewing function and aesthetics for patients with insufficient maxillary bone for standard implants. Bench testing confirms mechanical integrity; MR compatibility is established.

Clinical Evidence

Literature review of 971 smooth zygomatic implants in 397 patients showed survival rates of 93.3% to 100% over 11 years. Predicate clinical data (416 implants, 222 patients) showed similar survival rates (93.3% to 100%). Adverse events (implant failure, sinusitis, paresthesia, etc.) are consistent with known risks for zygomatic implants.

Technological Characteristics

Implants: Commercially pure Titanium Grade 4 (ASTM F67); sand-blasted/acid-etched (Neoporos) surface; 3.5/3.75mm diameter. Abutments/Copings: Titanium alloy (Ti6Al4V-ELI, ASTM F136); TiN coating on copings. Sterilization: Gamma radiation (implants), Ethylene Oxide (abutments/copings), both SAL 10^-6. Single-use.

Indications for Use

Indicated for patients with severe maxilla bone resorption requiring zygomatic implants for prosthetic support. Used in one or two-stage surgical procedures for multiple unit restorations, including immediate loading when primary stability is achieved. Contraindications include lack of primary stability or inadequate occlusal load.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

Neodent Implant System - Zygomatic Implants and Abutments (K190718)

Reference Devices

Noris Medical - Zygomatic Dental Implant System (K151909)
Neodent Implant System - Mini Abutment 60° (K203542)
Noris Medical Dental Implants System (K210356)
Neodent Implant System - GM Line (K173902)
MRI Compatibility for Existing Neodent Implant System (K182620)

Related Devices

K252031 — Adin Long Dental Implant System · Adin Dental Implant Systems , Ltd. · Mar 23, 2026
K151909 — Noris Medical Zygomatic Dental Implant System · Noris Medical , Ltd. · Apr 8, 2016
K243834 — NobelZygoma TiUltra Implant system · Nobel Biocare AB · Aug 25, 2025
K153064 — Blue Sky Bio Zygomatic Implant System · Blue Sky Bio, LLC · Apr 29, 2016
K161598 — NobelZygoma 0° · Nobel Biocare AB · Mar 14, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, 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) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ### 510(k) Summary ### 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.…