(94 days)
Not Found
No
The 510(k) summary describes a standard dental implant system and does not mention any AI or ML components in the device description, intended use, or performance studies.
No
The device restores chewing function, which is a physiological function, but it does so by providing support for prosthetic devices (artificial teeth), not by directly treating a disease or condition in a therapeutic manner.
No
The device is intended to be surgically placed to provide support for prosthetic devices (artificial teeth) and restore chewing function, indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly states it is a system of physical implants and abutments made of titanium, intended for surgical placement in bone. This indicates a hardware-based medical device, not software-only.
Based on the provided information, the Neodent Implant System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body.
- Neodent Implant System Function: The description clearly states that the Neodent Implant System is "surgically placed in the bone of the upper or lower jaw" to support prosthetic devices. This is an implantable medical device used within the body for structural support and restoration of function.
The intended use, device description, and anatomical site all point to a device that is surgically implanted, not used for testing biological samples in a lab setting.
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
Neodent Implant System implants included in this submission are threaded, self tapping, root form, endosseous dental implants with an external hex abutment interface. They are made of commercially pure titanium, with a surface that is grit blasted and acid etched. Implants are provided in both a straight, double thread design and a tapered, single thread design. In addition, multiple straight abutments are provided for each diameter implant for both cement retained and screw retained prostheses.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K002037, K050406, K033922, K041295, K022859, K053384, K073141
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
510(k) Summary
JJGC Indústria e Comércio de Materiais Dentários SA Neodent Implant System
July 15, 2010
AUG 0-2 2010
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ADMINISTRATIVE INFORMATION
Manufacturer Name:
JJGC Indústria e Comércio de Materiais Dentários SA Av. Juscelino Kubitschek de Oliveira, 3291 - CIC Curitiba - PR - CEP, 81270-200, Brazil +5 41 2169 4071 Telephone: +5 41 2169 4046 Fax:
Official Contact:
Holger Heussinger
Representative/Consultant:
Kevin A. Thomas, PhD Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 USA Telephone: +1 (858) 792-1235 +1 (858) 792-1236 Fax: email: kthomas@paxmed.com flarson@paxmed.com
DEVICE NAME AND CLASSIFICATION
ﺔ ﺍﻟﺘ
Trade/Proprietary Name: Common Name:
Classification Regulations:
Product Code
Classification Panel: Reviewing Branch:
Neodent Implant System Endosseous dental implant Endosseous dental implant abutment 21 CFR 872.3640 21 CFR 872.3630 DZE NHA . . Dental Products Panel : 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
1
restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.
DEVICE DESCRIPTION
Neodent Implant System implants included in this submission are threaded, self tapping, root form, endosseous dental implants with an external hex abutment interface. They are made of commercially pure titanium, with a surface that is grit blasted and acid etched. Implants are provided in both a straight, double thread design and a tapered, single thread design. In addition, multiple straight abutments are provided for each diameter implant for both cement retained and screw retained prostheses.
EQUIVALENCE TO MARKETED DEVICE
JJGC Indústria e Comércio de Materiais Dentários SA demonstrated that for the purposes of FDA's regulation of medical devices, the Neodent Implant System is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices:
Lifecore Biomedical Dental Implant Systems cleared under K002037. Nobel Biocare NOBELSPEEDY™ Implants cleared under K050406, Straumann ITT® Dental Implant System cleared under K033922, Straumann synOcta® Prosthetics cleared under K041295, Straumann UCLA Gold Abutment cleared under K022859, Astra Tech Fixture MicroThread™ OsseoSpeed™ cleared under K053384, and Thommen Medical SPI® ART Abutment cleared under K073141.
The subject device and the predicate devices have the same intended use and have the same technological characteristics. The subiect and predicate implants are all made of commercially pure titanium conforming to ASTM F67 and have similar surface treatments. The subject and predicate abutments are also made of the same materials (titanium alloy, gold alloy, zirconia). The subject and predicate devices encompass the same range of physical dimensions, including diameter and length of the implants, and diameter, height, and gingival height of the abutments. The subject and predicate devices are packaged in similar materials and sterilized using similar methods.
In summary, the Neodent Implant System has the following similarities to the predicate devices:
- . has the same intended use,
- uses the same operating principle, .
- incorporates the same basic design, .
- incorporates the same or very similar materials, and .
- has similar packaging and is sterilized using the same materials and processes. .
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JJGC Industria E Comercio De Materiais Dentarios S Mr. Kevin A. Thomas Regulatory Affairs PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
AUG 0 2 2010
Re: K101207
·
Trade/Device Name: Neodent Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II · Product Code: DZE Dated: July 16, 2010 Received: July 19, 2010
Dear Mr. 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.
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Page 2- Mr. 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
ph foc
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
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510(k) Premarket Notification
Neodent Implant System
Indications for Use
510(k) Number (if known):
Device Name: Neodent Implant System
AUG 0 % 2010
Indications for Use:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or I neer 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)
A. Betz MS. Lorti. Susan Runner
Page 1 of _l
Division Sign-Offg Division of Anestheslology, General Hospital Infection Control, Dental Devices
510(k) Number: K102087
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