(113 days)
No
The summary describes a physical implant and abutment device and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are focused on mechanical and biological properties.
Yes
The device is described as "Zygomatic Implants," which are surgically installed to "restore patient esthetics and chewing function" in cases of severe jaw resorption. This directly indicates a therapeutic purpose.
No
Explanation: The device is an implant and abutment system designed for surgical installation to restore patient esthetics and chewing function, not to identify or determine the nature of a disease or condition.
No
The device description explicitly states the device is a physical implant made of titanium and an abutment made of titanium alloy. It also details sterilization methods and mechanical testing, all indicative of a hardware device.
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, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this device is a surgical implant intended for installation directly into the zygoma bone to restore esthetics and chewing function. It is a physical device placed within the body.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient. The device's function is mechanical support and integration with bone.
Therefore, this device falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The subject implant devices are single use devices, provided sterile by Gamma Radiation, made of commercially pure Titanium grade 4 (ASTM F67 – ISO 5832-2). The Zygomatic Implant with an external diameter of 4.0 mm, conical apex, helical flutes, trapezoidal thread and GM prosthetic interface. Indicated for rehabilitation surgical procedures in atrophic maxilla cases, for installation in the zygomatic bone.
The subject abutment devices are single use devices, provided sterile by Ethylene Oxide, made of Titanium allov (TI6AI4V-ELI). They are 45 degrees prosthetic abutments with anti-rotational feature, anatomic gingiva region and GM prosthetic interface to be installed on the implant, offering a structure to support the prosthesis. Indicated for rehabilitation of screw-retained bridges.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Zygoma region; posterior (pre-molar/ molar) region; anterior region; zygomatic bone; atrophic maxilla.
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)
Dynamic fatigue test per ISO 14801 was performed to determine the fatigue strength for implant construct assembled with prosthetic abutment for multi-unit prosthesis, assembled with GM Zygomatic Implants, according to FDA Guidance.
Torsion Test was performed to evaluate the GM Zygomatic Implant and the screw of GM Exact Mini Conical Abutment (45 Degrees) under static torsional loading.
Insertion test was performed to evaluate the insertion torque of the GM Zygomatic Implant when inserted into jawbones material representing bone type II, III and IV.
Sterilization of the subject implants via gamma irradiation using a protocol of 25 kGy minimum dose has been performed according to the requirements stablished by ISO 11137-2. A minimum Sterility Assurance Level (SAL) of 1 x 10-6 has been validated. The sterility information and the sterile barrier validation was leveraged from K141777 for the implants.
Sterilization of the subject abutments via ethylene oxide gas using the overkill method has been performed according to the requirements of ISO 11135. A minimum Sterility Assurance Level (SAL) of 1 x 10 6 has been validated. The sterility information and the sterile barrier validation was leveraged from K163194 for the abutments.
Ethylene oxide residuals have been assessed per ISO 10993-7. Residuals are within accepted limits.
Biological Safety Assessment guided by ISO 10993-1, was performed for GM Zygomatic and GM Exact Mini Conical Abutment.
Cytotoxicity testing was performed per ISO 10993-5.
Chemical characterization was performed per ISO 10993-18.
Biocompatibility sample preparation was performed per ISO 10993-12. The biocompatibility information for implants was leveraged from K141777 and for abutments was leveraged from K163194.
The MRI labeling was leveraged from K182620.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Image /page/0/Picture/0 description: The image 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.
July 11 , 2019
JJGC Industria e Comercio de Materiais Dentarios S.A. % Jennifer Jackson Director of Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K190718
Trade/Device Name: Zygomatic Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: March 20, 2019 Received: March 20, 2019
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 (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 located 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
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.
For comprehensive regulatory information about mediation-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.
for Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190718
Device Name
Zygomatic Implants
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| [X] Prescription Use (Part 21 CFR 801 Subpart D) | [ ] Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K190718 – Neodent Implant System – Zygomatic Implants and Abutments
K190718
510(k) Summary
| ADMINISTRATIVE INFORMATION | |||
|---|---|---|---|
| Sponsor | JJGC Indústria e Comércio de Materiais Dentários SA (dba Neodent) | ||
| Av. Juscelino Kubitschek de Oliveira, 3291 | |||
| Curitiba, Parana, Brazil 81270-200 | |||
| Registration No.: 3008261720 | |||
| Owner/Operator No.: 10031702 | |||
| Contact Person | Jennifer M. Jackson, MS | ||
| Director of Regulatory Affairs, | |||
| Straumann USA | |||
| e-mail: jennifer.jackson@straumann.com | |||
| Telephone (978) 747-2509 | |||
| Date Prepared | 11/Jul/2019 | ||
| Preparer / Alternate Contact | Mariana Soares Hartmann | ||
| Regulatory Affairs Analyst | |||
| e-mail: mariana.hartmann@neodent.com | |||
| DEVICE NAME AND CLASSIFICATION | |||
| Trade/ Proprietary Name | Neodent Implant System - Zygomatic Implants and Abutments | ||
| Common Name | Endosseous dental implant | ||
| Endosseous dental implant abutment | |||
| Classification Name | Implant, Endosseous, Root-Form | ||
| Endosseous dental implant abutment | |||
| Classification Regulations | 21 CFR 872.3640, Class II | ||
| Product Code | DZE/NHA | ||
| Classification Panel | Dental Products Panel | ||
| Reviewing Branch | Dental Devices Branch | ||
| PREDICATE DEVICE INFORMATION | |||
| Primary Predicate Device | K141777, Neodent Implant System, JJGC Indústria e Comércio de Materiais | ||
| Dentários S.A | |||
| Reference Predicate Devices | K163194, Neodent Implant System – GM Line, JJGC Indústria e Comércio de | ||
| Materiais Dentários S.A | |||
| K161598, NobelZygoma 0°, Nobel Biocare AB |
4
K182620, MRI Compatibility For Existing Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A
INDICATIONS FOR USE
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) 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.
SUBJECT DEVICE DESCRIPTIONS
The subject implant devices are single use devices, provided sterile by Gamma Radiation, made of commercially pure Titanium grade 4 (ASTM F67 – ISO 5832-2). The Zygomatic Implant with an external diameter of 4.0 mm, conical apex, helical flutes, trapezoidal thread and GM prosthetic interface. Indicated for rehabilitation surgical procedures in atrophic maxilla cases, for installation in the zygomatic bone.
The subject abutment devices are single use devices, provided sterile by Ethylene Oxide, made of Titanium allov (TI6AI4V-ELI). They are 45 degrees prosthetic abutments with anti-rotational feature, anatomic gingiva region and GM prosthetic interface to be installed on the implant, offering a structure to support the prosthesis. Indicated for rehabilitation of screw-retained bridges.
5
TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | ||
|---|---|---|---|---|
| Neodent Implant System - Zygomatic | ||||
| Implants and Abutments | ||||
| JJGC Indústria e Comércio de Materiais | ||||
| Dentários S.A. | K141777 | |||
| Neodent Implant System | ||||
| JJGC Indústria e Comércio de Materiais | ||||
| Dentários S.A. | K161598 | |||
| NobelZygoma 0° | ||||
| Nobel Biocare AB | EQUIVALENCE DISCUSSION | |||
| Indications | ||||
| for Use | 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. | 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. | 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. | Same | |||
| The subject devices and the primary | ||||
| predicate devices have the same | ||||
| Indications for Use. | ||||
| Design | Threaded root-form implant to be used | |||
| with matching abutments, made of | ||||
| titanium grade 4 | ||||
| 45° angled abutments made of titanium | ||||
| alloy, intended exclusively for use with | ||||
| the GM Zygomatic implants | Threaded root-form implant to be used | |||
| with matching abutments, made of | ||||
| titanium grade 4 | ||||
| Angled abutments made of titanium | ||||
| alloy | Tapered with cut out flutes | |||
| 45° and 60° angled abutments made of | ||||
| titanium alloy | Equivalent | |||
| For the predicate, the coronal aspect of | ||||
| the implant incorporated the 45° angle | ||||
| and the abutments were straight. For the | ||||
| subject devices, this is reversed. The | ||||
| subject abutments present the same | ||||
| angulation as the reference predicate | ||||
| devices K161598 (45°) | ||||
| The design of the subject device is | ||||
| equivalent to that of the reference device | ||||
| K163194. | ||||
| Reusable | No | No | No | Same |
| Endosseous | ||||
| Diameter (mm) | 4.0 | 4.4 | 4.5 | Equivalent |
| The difference is insignificant. | ||||
| Length (mm) | ||||
| (Implants) | 30; 35; 37.5; 40; 42.5; 47.5; 50; 52.5; 55 | External hex: 30; 35; 40; 45; 47.5; 50; | ||
| 52.5 | ||||
| Morse Taper: 30; 35; 40; 42.5; 45; 47.5; | ||||
| 50; 52.5 | 30, 35, 37.5, 40, 42.5, 45, 47.5, 50 | Equivalent | ||
| Similar range of sizes. | ||||
| Gingival Height (mm) | ||||
| (Abutments) | 1.5 and 2.5 | 1.5; 2; 3; 4; 5; and 6. | 6, 8; 10 | Equivalent |
| Similar range of sizes, having the predicate the biggest range, covering the subject devices sizes. | ||||
| Implant platform Ø (mm) | 4.0 | 4.1 | 4.5 | Equivalent |
| The difference is insignificant. | ||||
| Implant surfaces | Sand blasted, acid etched NeoPoros surface. | Sand blasted, acid etched NeoPoros surface. | TiUnite | Same |
| The subject devices and the primary predicate devices present the same implant surfaces. | ||||
| Sterilization Method | Implants | |||
| Gamma Radiation to an SAL of 1x10-6 | ||||
| Abutments | ||||
| Ethylene Oxide to an SAL of 1x10-6 | Implants | |||
| Gamma Radiation to an SAL of 1x10-6 | ||||
| Abutments | ||||
| Ethylene Oxide to an SAL of 1x10-6 | Implants | |||
| Gamma Irradiation | ||||
| Abutments | ||||
| Gamma Irradiation | Same | |||
| The subject devices and the primary predicate devices present the same Sterilization Methods. | ||||
| Sterile Barrier | Implants | |||
| PET blister with Tyvek 1059B lidding | ||||
| Abutments | ||||
| PET blister with Tyvek 1059B lidding | Implants | |||
| PET blister with Tyvek 1059B lidding | ||||
| Abutments | ||||
| PET blister with Tyvek 1059B lidding | N/A | Same | ||
| The subject devices and the primary predicate devices present the same Sterile Barrier. |
6
7
The subject devices and the primary predicate device K141777 have the same intended use and Indications for Use statements. The subject device and the primary predicate device K141777 have implants with similar platform and endosseous diameter, similar lengths, same surface treatment, same sterilization methods and same sterile barrier. The subject devices and the primary predicate device have abutments with similar range of Gingival Height, same raw material, same sterilization method and same sterile barrier.
PERFORMANCE DATA
Dynamic fatigue test per ISO 14801 was performed to determine the fatigue strength for implant construct assembled with prosthetic abutment for multi-unit prosthesis, assembled with GM Zygomatic Implants, according to FDA Guidance.
Torsion Test was performed to evaluate the GM Zygomatic Implant and the screw of GM Exact Mini Conical Abutment (45 Degrees) under static torsional loading.
Insertion test was performed to evaluate the insertion torque of the GM Zygomatic Implant when inserted into jawbones material representing bone type II, III and IV.
Sterilization of the subject implants via gamma irradiation using a protocol of 25 kGy minimum dose has been performed according to the requirements stablished by ISO 11137-2. A minimum Sterility Assurance Level (SAL) of 1 x 106 has been validated. The sterility information and the sterile barrier validation was leveraged from K141777 for the implants.
Sterilization of the subject abutments via ethylene oxide gas using the overkill method has been performed according to the requirements of ISO 11135. A minimum Sterility Assurance Level (SAL) of 1 x 10 6 has been validated. The sterility information and the sterile barrier validation was leveraged from K163194 for the abutments.
Ethylene oxide residuals have been assessed per ISO 10993-7. Residuals are within accepted limits.
Biological Safety Assessment guided by ISO 10993-1, was performed for GM Zygomatic and GM Exact Mini Conical Abutment.
Cytotoxicity testing was performed per ISO 10993-5.
Chemical characterization was performed per ISO 10993-18.
Biocompatibility sample preparation was performed per ISO 10993-12. The biocompatibility information for implants was leveraged from K141777 and for abutments was leveraged from K163194.
The MRI labeling was leveraged from K182620.
CONCLUSION
The subject device and the primary predicate device K141777 have the same intended use, have similar designs and technological characteristics, and are materials. The data included in this submission demonstrate that the subject device is substantially equivalent to the predicate device.