(211 days)
No
The 510(k) summary describes a standard dental implant system and its mechanical and biological performance. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No.
A therapeutic device is typically understood to alleviate or cure a disease or medical condition. While this device restores chewing function, which can improve quality of life, dental implants are generally considered prosthetic devices rather than devices that treat a disease or condition. Its primary function is to support prosthetic teeth to restore function, not to treat a disease.
No
The device is a dental implant system designed to support prosthetic devices for restoring chewing function. Its intended use and description do not involve diagnosing any condition or disease.
No
The device description clearly states it is a physical dental implant made of titanium, intended for surgical placement. It also describes physical characteristics like external diameters, lengths, and threads. The performance studies described are physical tests (fatigue, torsion, insertion, pull-out) and sterilization/biocompatibility, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "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." This describes a surgical implant used for structural support within the body.
- Device Description: The description details a "dental implant device" made of titanium, designed for surgical placement.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in a laboratory or clinical setting to analyze biological samples.
Therefore, the Neodent Implant System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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. The Neodent GM Helix LG implants can be placed bicortically in cases of reduced bone density. The Neodent GM Helix LG implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The subject dental implant devices are single use devices, provided sterile by Gamma Radiation, made of commercially pure Titanium grade 4 (ASTM F67 – ISO 5832-2). The GM Helix LG Implant is a long conical implant with external diameters of 3.75 and 4.0 mm and lengths of 20, 22.5 and 25 mm. It has trapezoidal threads, conical apex with spherical tip and helical chambers, cylindrical body and Grand Morse prosthetic interface. The GM Helix LG implants share the same design characteristics as the existing GM Helix but are longer than the previously cleared range of implants. Indicated 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the 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)
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 Helix LG Implants, according to FDA Guidance.
Torsion Test was performed to evaluate the GM Helix LG Implant under static torsional loading. Insertion test was performed to evaluate the insertion torque of the GM Helix LG Implant when inserted into sawbones material representing bone type II, III and IV.
Pull-out testing was performed to compare the Axial Pull-out Strength between the subject devices and the predicate devices.
Sterilization of the subject implants via gamma irradiation using a protocol of 25 kGy minimum dose has been performed according to the requirements established by ISO 11137-2. A minimum Sterility Assurance Level (SAL) of 1 x 10 ° has beenvalidated.
Biological Safety Assessment guided by ISO 10993-1, Cytotoxicity guided by ISO 10993-5 and Chemical characterization guided by ISO 10993-18 were performed for GM Helix LG implants. Biocompatibility sample preparation was performed per ISO 10993-12.
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
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November 9, 2019
JJGC Industria e Comercio de Materiais Dentarios SA % Jennifer M. Jackson Director Regulatory Affairs Straumann 60 Minuteman Road Andover, Massachusetts 01810
Re: K190958
Trade/Device Name: Neodent Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: October 10, 2019 Received: October 11, 2019
Dear Jennifer M. 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 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,
Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190958
Device Name Neodent Implant System
Indications for Use (Describe)
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. The Neodent GM Helix LG implants can be placed bicortically in cases of reduced bone density. The Neodent GM Helix LG implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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| 510(k) Summary | |
|---|---|
| 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 |
| Director of Regulatory Affairs, | |
| Straumann USA | |
| E-Mail: jennifer.jackson@straumann.com | |
| Telephone (978) 747-2509 | |
| Date Prepared | 08/Nov/2019 |
| Preparer / Alternate Contact | Mariana Soares Hartmann |
| Regulatory Affairs Analyst | |
| mariana.hartmann@neodent.com | |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/ Proprietary Name | |
| Common Name | Neodent Implant System |
| Endosseous dental implant | |
| Classification Name | Implant, Endosseous, Root-Form |
| Classification Regulations | |
| Product Code | 21 CFR 872.3640, Class II |
| DZE | |
| Classification Panel | |
| Reviewing Branch | Dental Products Panel |
| Dental Devices Branch | |
| PREDICATE DEVICE INFORMATION | |
| Primary Predicate Device | K160119, NobelSpeedy® Groovy, Nobel Biocare AB |
| Reference Devices | K163194, Neodent Implant System - GM Line, JJGC Indústria |
| e Comércio de Materiais Dentários S.A | |
| K180536, Neodent Implant System - GM Line, JJGC Indústria | |
| Comércio de Materiais Dentários S.A | |
| K190718, Neodent GM Zygomatic Implants – GM Line, JJGC | |
| Indústria e Comércio de Materiais Dentários S.A |
4
INDICATIONS FOR USE
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. The Neodent GM Helix LG implants can be placed bicortically in cases of reduced bone density. The Neodent GM Helix LG implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.
SUBJECT DEVICE DESCRIPTIONS
The subject dental implant devices are single use devices, provided sterile by Gamma Radiation, made of commercially pure Titanium grade 4 (ASTM F67 – ISO 5832-2). The GM Helix LG Implant is a long conical implant with external diameters of 3.75 and 4.0 mm and lengths of 20, 22.5 and 25 mm. It has trapezoidal threads, conical apex with spherical tip and helical chambers, cylindrical body and Grand Morse prosthetic interface. The GM Helix LG implants share the same design characteristics as the existing GM Helix but are longer than the previously cleared range of implants. Indicated 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.
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | |
|---|---|---|
| GM Helix LG (K190958) | ||
| Neodent Implant System | ||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | K160119 | |
| NobelSpeedy® Groovy Nobel | ||
| Biocare AB | ||
| Indications for | ||
| Use | 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. The Neodent GM Helix LG implants can be placed | ||
| bicortically in cases of reduced bone density. The Neodent | ||
| GM Helix LG implants are only indicated for multiple unit | ||
| restorations in splinted applications that utilize at least | ||
| two implants. | NobelSpeedy® Groovy implants are endosseous implants | |
| intended to be surgically placed in the upper or lower jaw bone | ||
| for anchoring or supporting tooth replacements to restore | ||
| patient esthetics and chewing function. NobelSpeedy® Groovy | ||
| implants are indicated for single or multiple unit restorations in | ||
| splinted or non- splinted applications. This can be achieved by a | ||
| 2- stage or 1-stage surgical technique in combination with | ||
| immediate, early or delayed loading protocols, recognizing | ||
| sufficient primary stability and appropriate occlusal loading for | ||
| the selected technique. Implants allow also for bi-cortical | ||
| anchorage in cases of reduced bone density NobelSpeedy® | ||
| Groovy implants 20, 22, 25 mm when placed in the maxilla are | ||
| only indicated for multiple unit restorations in splinted | ||
| applications that utilize at least two implants. | ||
| Design | Threaded root-form implant with internal GM Morse taper | |
| connection with internal hex. | Single lead thread with groove, tapered apex with bone | |
| cutting flutes and external hex. | ||
| Device Material | Commercially Pure Titanium (ASTM F67) | Commercially Pure Titanium |
| Reusable | No | No |
| Platform | ||
| Diameter | 3.75; 4.0 mm | 4.0 mm |
| Length | 20; 22.5; 25 mm | 20; 22; 25 mm |
| Surface | Machined, acid-etched NeoPoros surface. | TiUnite |
TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE
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| Sterilization Method | Gamma Irradiation to an SAL of 1x10-6 | Gamma Irradiation | |
|---|---|---|---|
| Placement | Single or Bicortically in mandible or maxilla | Single or Bicortically in mandible or maxilla |
SUBSTANTIAL EQUIVALENCE DISCUSSION
The subject devices and the primary predicate device have equivalent intended use and Indications for Use statements. Both can be placed single or bicortically in mandible or maxilla. The subject devices and the primary predicate devices also share the same material of composition, the same sterilization method and range of length and present similar designs and platform diameter. The difference between the subject devices and the predicate devices is the Ø3.75 mm device. This change in technology is supported by the torsion test and pull out test, both included as appendices of this submission. The subject devices have the same thread design and the same implant-to-abutment interface design as the reference predicate devices.
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 Helix LG Implants, according to FDA Guidance.
Torsion Test was performed to evaluate the GM Helix LG Implant under static torsional loading. Insertion test was performed to evaluate the insertion torque of the GM Helix LG Implant when inserted into sawbones material representing bone type II, III and IV.
Pull-out testing was performed to compare the Axial Pull-out Strength between the subject devices and the predicate devices.
Sterilization of the subject implants via gamma irradiation using a protocol of 25 kGy minimum dose has been performed according to the requirements established by ISO 11137-2. A minimum Sterility Assurance Level (SAL) of 1 x 10 ° has beenvalidated.
Biological Safety Assessment guided by ISO 10993-1, Cytotoxicity guided by ISO 10993-5 and Chemical characterization guided by ISO 10993-18 were performed for GM Helix LG implants. Biocompatibility sample preparation was performed per ISO 10993-12.
CONCLUSION
The data included in this submission demonstrate that the subject devices are substantially equivalent to the predicate devices.