(102 days)
No
The document describes a dental implant system and its components, focusing on materials, dimensions, and mechanical testing. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
Yes.
The device is surgically placed to support prosthetic devices and restore chewing function, which addresses a medical condition or improves a health function.
No
The device is an implant system designed to support prosthetic devices and restore chewing function, not for diagnosing conditions.
No
The device description clearly outlines physical components such as dental implants and abutments made from titanium, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical placement in the bone to support prosthetic devices and restore chewing function. This is a surgical and restorative purpose, not a diagnostic one.
- Device Description: The description details the physical components of dental implants and abutments, which are surgically implanted devices.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (blood, tissue, etc.) or providing information for diagnosis. The device's function is purely mechanical and structural.
- Performance Studies: The performance studies focus on mechanical properties like biocompatibility, engineering analysis, dimensional analysis, and fatigue testing, which are relevant to implanted devices, not diagnostic tests.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
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. Multiple tooth applications may be rigidly splinted.
Product codes
DZE, NHA
Device Description
The purpose of this submission is to expand the Neodent Implant System components cleared under K101207, which included dental implants with an external hex abutment interface. The external hex additions include Titamax Smart EX, and Drive Smart implants that are provided with a new implant mount that can be used as a temporary abutment. Additional straight, angled and ball-type abutments with external hex interfaces are also included in this submission.
All of the subject device external implants are threaded, self-tapping, root form, endosseous dental implants with a grit blasted and acid etched endosseous surface. All implants have a smooth machined collar on the transgingival surface. The Titamax Smart implants are provided in five endosseous thread diameters (3.3, 3.75, 4.0, 4.5, 5.0 mm), three platform diameters (3.3, 4.1, 5.0 mm), and five overall lengths (9, 11, 13, 15, 17 mm). The Titamax Smart EX implants are provided in two endosseous thread diameters (3.75, 4.0 mm), one platform diameter (4.1 mm), and six overall lengths (9, 11, 13, 15, 17, 19 mm). The Drive Smart implants are provided in three endosseous thread diameters (3.5, 4.3, 5.0 mm), three platform diameters (3.3, 4.3, 5.0 mm), and five overall lengths (8, 10, 11.5, 13, 16 mm). All implants are made from commercially pure titanium conforming to ASTM F67.
This submission includes the following abutments: the Smart Mount in three platform diameters (3.3, 4.1/4.3, 5.0 mm); Conical Abutments (platform diameter 3.3 mm); Angled Mini Conical abutments angled 17° or 30°, in four platform diameters (3.3, 4.1, 4.3, 5.0 mm), and gingival heights from 2 mm to 5 mm; SF Universal Post abutments (platform diameter 4.5 mm); Angled Post abutments angled 17° or 30° in four platform diameters (3.3. 4.1. 4.3, 5.0 mm), and gingival heights from 2 mm to 5 mm; and Equator Attachments for overdentures or partial dentures in three platform diameters (4.1, 4.3, 5.0 mm) and gingival heights from 2 mm to 5 mm. All abutments are made from titanium alloy conforming to ASTM F136.
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)
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility, engineering analysis, dimensional analysis, static and dynamic compression-bending testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. Fatigue testing demonstrated the subject device to be equivalent to the predicate devices.
Clinical data were not submitted in this premarket notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Neodent Implant System
FEB 2 4 2014
な
510(k) Summary
JJGC Indústria e Comércio de Materiais Dentários SA
Neodent Implant System
November 15, 2013
| Manufacturer Name | JJGC Indústria e Comércio de Materiais Dentários SA
Av. Juscelino Kubitschek de Oliveira, 3291 - CIC | |
|---------------------------|---------------------------------------------------------------------------------------------------------|--------------------|
| | Curitiba, Paraná, 81270-200, Brazil | |
| | Telephone: | +55 41 2169 1003 |
| | Fax: | +55 41 2169 1043 |
| Official Contact | Jafte Carneiro Fagundes da Silva | |
| | Chief Compliance, Legal and Regulatory Officer – CCLRO | |
| Representative/Consultant | Kevin A. Thomas, PhD | |
| | PaxMed International, LLC | |
| | 12264 El Camino Real, Suite 400 | |
| | San Diego, CA 92130 | |
| | Telephone | +1 (858) 792-1235 |
| | Fax | +1 (858) 792-1236 |
| | Email | kthomas@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | Neodent Implant System |
|---|---|
| Common Name | Endosseous dental implant |
| Endosseous dental implant abutment | |
| Classification Regulations | 21 CFR 872.3640 |
| Product Code | DZE |
| NHA | |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
INTENDED 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. Multiple tooth applications may be rigidly splinted.
1
DEVICE DESCRIPTION
The purpose of this submission is to expand the Neodent Implant System components cleared under K101207, which included dental implants with an external hex abutment interface. The external hex additions include Titamax Smart EX, and Drive Smart implants that are provided with a new implant mount that can be used as a temporary abutment. Additional straight, angled and ball-type abutments with external hex interfaces are also included in this submission.
All of the subject device external implants are threaded, self-tapping, root form, endosseous dental implants with a grit blasted and acid etched endosseous surface. All implants have a smooth machined collar on the transgingival surface. The Titamax Smart implants are provided in five endosseous thread diameters (3.3, 3.75, 4.0, 4.5, 5.0 mm), three platform diameters (3.3, 4.1, 5.0 mm), and five overall lengths (9, 11, 13, 15, 17 mm). The Titamax Smart EX implants are provided in two endosseous thread diameters (3.75, 4.0 mm), one platform diameter (4.1 mm), and six overall lengths (9, 11, 13, 15, 17, 19 mm). The Drive Smart implants are provided in three endosseous thread diameters (3.5, 4.3, 5.0 mm), three platform diameters (3.3, 4.3, 5.0 mm), and five overall lengths (8, 10, 11.5, 13, 16 mm). All implants are made from commercially pure titanium conforming to ASTM F67.
This submission includes the following abutments: the Smart Mount in three platform diameters (3.3, 4.1/4.3, 5.0 mm); Conical Abutments (platform diameter 3.3 mm); Angled Mini Conical abutments angled 17° or 30°, in four platform diameters (3.3, 4.1, 4.3, 5.0 mm), and gingival heights from 2 mm to 5 mm; SF Universal Post abutments (platform diameter 4.5 mm); Angled Post abutments angled 17° or 30° in four platform diameters (3.3. 4.1. 4.3, 5.0 mm), and gingival heights from 2 mm to 5 mm; and Equator Attachments for overdentures or partial dentures in three platform diameters (4.1, 4.3, 5.0 mm) and gingival heights from 2 mm to 5 mm. All abutments are made from titanium alloy conforming to ASTM F136.
EQUIVALENCE TO MARKETED DEVICE
Neodent Implant System is substantially equivalent in indications and design principles to the following legally marketed predicate devices:
- JJGC Indústria e Comércio de Materiais Dentários SA, Neodent Implant System, K101207
- JJGC Indústria e Comércio de Materiais Dentários SA, Neodent Implant System, K 101945
- JJGC Indústria e Comércio de Materiais Dentários SA, Neodent Implant System, K123022
The implants of the subject Neodent Implant System have similar designs and dimensions, use the same materials, and have the same surface as those cleared under K101207, K101945, and K 123022. The abutments of the subject Neodent Implant System have similar designs and are made from the same material as those cleared under K101207, K101945, and K123022.
2
510(k) Summary
The subject device has similar packaging and is sterilized using the same materials and processes as described in K101207, K101945, and K123022.
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility, engineering analysis, dimensional analysis, static and dynamic compression-bending testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. Fatigue testing demonstrated the subject device to be equivalent to the predicate devices.
Clinical data were not submitted in this premarket notification.
CONCLUSION
The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject device and predicate devices encompass the same range of physical dimensions, including diameter and length of the implants, and diameter, height and angle of the abutments. The subject and predicate devices are packaged in similar materials and sterilized using similar methods. Any differences in the technological characteristics do not raise new issues of safety or efficacy. The device is safe and effective for its intended use and performs as well as or better than the predicate devices.
The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 10903 New Hamnshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 24, 2014
JJGC Indústria e Comércio de Materiais Dentários SA C/O Dr. Kevin A. Thomas, PhD Regulatory Affairs PaxMed International, Limited Liability Company 12264 El Camino Real, Suite 400 San Diego, CA 92130
Re: K133510
Trade/Device Name: Neodent Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE NHA Dated: January 28, 2014 Received: January 29, 2014
Dear Dr. Thomas:
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. 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.
4
Page 2 - Dr. Thomas
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/4/Picture/8 description: The image shows the text "Kwame O Ulmer-s". The text is arranged in two lines, with "Kwame O" on the top line and "Ulmer-s" on the bottom line. The text is in a bold, sans-serif font. The background of the image is filled with a pattern of small squares and lines.
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
for
Enclosure
5
510(k) Summary
Neodent Implant System
Indications for Use
K133510 510(k) Number:
Neodent Implant System Device Name:
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. Multiple tooth applications may be rigidly splinted.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Susan Runner
Mary S. Runner -S
DDSPM 2014.02.24
13:08:30 -05'00'