(121 days)
No
The summary describes a physical dental implant and its mechanical and biological properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an implant system to support prosthetic devices for restoring chewing function, which is a restorative rather than therapeutic purpose.
No.
The device is an implant for surgical placement in the jaw bone to support prosthetic devices for restoring chewing function, not for diagnosing conditions.
No
The device description clearly outlines a physical implant made of titanium, intended for surgical placement, and includes details about its material, manufacturing, sterilization, and mechanical properties. There is no mention of software as the primary or sole component.
No, 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". This describes a surgical implant used in vivo (within the body) to restore function.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used in vitro (outside the body).
- Device Description: The description details the physical characteristics, material, and sterilization of a surgical implant, not a device used for analyzing biological samples.
- Lack of IVD-related information: The document does not mention any analysis of biological samples, diagnostic purposes, or any components typically associated with IVD devices (reagents, analyzers, etc.).
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 procedures, for single or multiple unit restorations, and 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
Device Description
- Intended for single use;
- Provided sterile via gamma irradiation;
- Manufactured of commercially pure titanium (Ti) grade 4 per ASTM F67;
- Morse Taper prosthetic interface with internal hexagonal indexer, exclusively from the Grand Morse (GM) line;
- Body center and apex with conical format;
- Trapezoidal-profile double threads;
- Rounded apex end;
- Available in Neoporos and Acqua surfaces;
- Ø7.0 mm and 8, 10, 11.5, and 13 mm lengths;
- The subject devices are compatible with all the abutments of the Neodent Implant System that present the GM implant to abutment interface, previously cleared per K163194, K173902, K180536, K191191, and K1922229.
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)
Biocompatibility: 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 and Chemical characterization was performed per ISO 10993-18. The subject implants are made of unalloyed titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700), the same type of titanium used for fabrication of the predicate devices cleared under K163194 and K180536. The subject devices undergo to the same manufacturing processes to the cited predicate devices. The subject devices do not present a new worst case for biocompatibility and therefore, the predicate and reference device testing are relied upon for determining substantial equivalence.
Mechanical testing: Dynamic fatigue test per ISO 14801 was performed to determine the fatigue strength for the dental implant system, according to FDA Guidance. The tested subject devices exhibit a level of performance equivalent to that reviewed for the predicate devices. Insertion torque testing was also performed to determine insertion torque for the dental implants in Type III and Type IV bone.
Sterilization Validation: The subject implants are sterilized by Co gamma irradiation at a nominal dose of 25 kGy (2.5 Mrad). Sterilization has been validated by the VDma22 method, according to ISO 11137-1 and ISO 11137-2. The method achieved a Sterility Assurance Level 10-6. The Subject devices are not represented to be "pyrogen free". Routine endotoxin testing for NeoPoros and Acqua implants are performed monthly on representative samples of this group of products. The test limit is 20 EU/device as recommended by USP . The sterilization method presented for the subject devices is the same as for the predicate devices and has been previously reviewed under K163194 and K180536.
Shelf Life Validation: The subject implants have a shelf life of 5 years that was validated by accelerated aging according to ASTM F1980. The packaging was validated according to ISO 11607-1 and ISTA 2A. Sealing strength (ASTM F88), Dye Penetration (ASTM F1929), and Bubble Test (ASTM F2096) were conducted to verify the maintenance of the sterile barrier after storage.
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.
K163194, K180536, K101201, K192221
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.
September 4, 2020
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: K201225
Trade/Device Name: Neodent Implant System - GM Helix Implants 7.0 Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: June 12, 2020 Received: June 15, 2020
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 Part 803) for devices or post-marketing 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 (OS) 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.
for Srinivas Nandkumar, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K201225
Device Name
Neodent Implant System - GM Helix Implants 7.0
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 procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
Type of Use (Select one or both, as applicable)
Prescription Use (21 CFR Part 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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 | 03/Sep/2020 |
| Preparer / Alternate Contact | Mariana Soares Hartmann
Regulatory Affairs Analyst
E-mail: mariana.hartmann@neodent.com |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/ Proprietary Name
Common Name | Neodent Implant System - GM Helix Implants 7.0
Endosseous dental implant |
| Classification Name | Endosseous dental implant |
| 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 | K163194, Neodent Implant System – GM Line, JJGC Indústria e
Comércio de Materiais Dentários S.A |
| Reference Predicate Devices | K180536, Neodent Implant System – GM Line, JJGC Indústria e
Comércio de Materiais Dentários S.A
K101201, KAT Implant System - KAT Implants LLC |
4
Legacy2, SimplyLegacy2, K192221, Legacy3, Legacy4, SimplyLegacy3 Dental Implants; Legacy2, Legacy3, Legacy4 Fixture-Mounts, Implant Direct Sybron Manufacturing, LLC K182620 - MRI Compatibility For Existing Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A K193592 - Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants
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.
SUBJECT DEVICE DESCRIPTIONS
- Intended for single use;
- . Provided sterile via gamma irradiation;
- Manufactured of commercially pure titanium (Ti) grade 4 per ASTM F67;
- . Morse Taper prosthetic interface with internal hexagonal indexer, exclusively from the Grand Morse (GM) line;
- . Body center and apex with conical format;
- Trapezoidal-profile double threads;
- Rounded apex end;
- . Available in Neoporos and Acqua surfaces;
- Ø7.0 mm and 8, 10, 11.5, and 13 mm lengths;
- The subject devices are compatible with all the abutments of the Neodent Implant System that present the GM implant to abutment interface, previously cleared per K163194, K173902, K180536, K191191, and K1922229.
5
TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE | ||
|---|---|---|---|---|
| Neodent Implant System - GM Helix | ||||
| Implants 7.0 | ||||
| JJGC Indústria e Comércio de Materiais | ||||
| Dentários S.A. | K163194 | |||
| Neodent Implant System - GM Line | ||||
| JJGC Indústria e Comércio de Materiais | ||||
| Dentários S.A. | K101201 | |||
| KAT Implant System | ||||
| KAT Implants LLC | K192221 | |||
| Legacy4 | ||||
| Implant Direct Sybron Manufacturing LLC | ||||
| 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 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. | KAT Implant System Dental Implants | |||
| are indicated for restoration of | ||||
| edentulous maxilla and mandible, to | ||||
| provide support for removable | ||||
| dentures, fixed bridges, or to be used | ||||
| as a single tooth replacement. Single or | ||||
| splinted implants can be immediately | ||||
| loaded if good primary stability and | ||||
| appropriate occlusal loading is | ||||
| achieved. The implants can be placed | ||||
| in extraction sites or healed alveolar | ||||
| ridges. Immediate loading may not be | ||||
| appropriate in Type IV bone due to | ||||
| difficulty in achieving primary stability. | Legacy2, simplyLegacy2, Legacy3, | |||
| simplyLegacy3, and Legacy4 dental | ||||
| implants are two-piece implants for one- | ||||
| stage or two-stage surgical procedures. | ||||
| These implants are intended for use in | ||||
| partially and fully edentulous upper and | ||||
| lower jaws in support of single or multiple- | ||||
| unit restorations and terminal or | ||||
| intermediate abutment support for fixed | ||||
| bridgework. |
Implants can be indicated for immediate
loading when good primary stability has
been achieved and with appropriate
occlusal loading.
Narrow (3.2mmD) implants: Indicated for
single-tooth replacement (mandibular
central and lateral incisors; maxillary lateral
incisors), multiple-tooth replacements or
denture stabilization.
Short (.
The sterilization method presented for the subject devices is the same as for the predicate devices and has been previously reviewed under K163194 and K180536.
Shelf Life Validation
The subject implants have a shelf life of 5 years that was validated by accelerated aging according to ASTM F1980. The packaging was validated according to ISO 11607-1 and ISTA 2A. Sealing strength (ASTM F88), Dye Penetration (ASTM F1929), and Bubble Test (ASTM F2096) were conducted to verify the maintenance of the sterile barrier after storage.
CONCLUSION
The subject devices and the primary predicate devices K163194 have the same intended use, same design and technological characteristics, similar range of length, same sterilization method and are made of the same materials. The subject devices present a diameter that is contained within the range of diameters of the reference predicate devices. The data included in this submission demonstrate that the subject devices are substantially equivalent to the predicate devices.