(84 days)
No
The 510(k) summary describes dental implants and abutments, focusing on materials, dimensions, and compatibility with existing systems. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes.
The device, the Neodent Implant System, is intended to be surgically placed in the jaw bone to support prosthetic devices and restore chewing function, which qualifies as a therapeutic purpose.
No
Explanation: The device is described as an implant system intended to provide support for prosthetic devices, not to diagnose a condition.
No
The device description clearly details physical components (abutments made of titanium alloy) intended for surgical implantation, indicating it is a hardware medical device, not software-only.
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 for mechanical support, not a test performed on biological samples to diagnose a condition.
- Device Description: The description details the physical components of the implant system (abutments, materials, dimensions) and their compatibility with other implant parts. It does not mention any reagents, assays, or procedures for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device's function is purely mechanical and structural.
Therefore, the Neodent Implant System, as described, falls under the category of 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. Multiple tooth applications may be rigidly splinted.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The purpose of this submission is to expand the Neodent Implant System components cleared under K101945 and K123022. This submission includes Facility Universal Post and Equator Attachment CM abutments with a Morse taper interface. Facility Universal Post abutments are straight, post-type abutments for cemented prosthetic restorations. They are provided in one platform diameter (3.3 mm), gingival heights of 1 mm to 5 mm, and prosthetic heights of 4 mm and 6 mm. Facility Universal Post abutments are compatible with the Facility dental implants cleared in K123022, and with the Universal Post Cylinders cleared in K101945. Equator Attachment CM abutments are straight, ball-type abutments for the attachment of overdentures or partial dentures. They are provided in five gingival heights (1.5, 2.5, 4.5 and 5.5 mm). These abutments have a titanium nitride (TiN) coating for the purpose of creating a harder surface to increase wear resistance. This titanium nitride coating is identical to that used on the Neodent CM Mini Ball Attachment cleared in K101945, and the Facility Equator Attachment cleared in K123022. Equator Attachment CM abutments are compatible with Titamax CM, Titamax CM EX, and Alvim CM implants cleared in K101945, and with the CM Drive implants cleared in K123022. All abutments in this submission are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
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 and dimensional analysis. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above. Clinical data were not submitted in this premarket notification.
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.
Not Found
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
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
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Kr33696
ﯩﻨﯩﻐ
510(k) Summary
Neodent Implant System
."
FEB 2 5 2014
.. ""
510(k) Summary
JJGC Indústria e Comércio de Materiais Dentários SA
Neodent Implant System
December 2, 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 abutment |
| Classification Regulations | Class II, 21 CFR 872.3630 |
| Product Code | 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.
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·
DEVICE DESCRIPTION
The purpose of this submission is to expand the Neodent Implant System components cleared under K101945 and K123022. This submission includes Facility Universal Post and Equator Attachment CM abutments with a Morse taper interface. Facility Universal Post abutments are straight, post-type abutments for cemented prosthetic restorations. They are provided in one platform diameter (3.3 mm), gingival heights of 1 mm to 5 mm, and prosthetic heights of 4 mm and 6 mm. Facility Universal Post abutments are compatible with the Facility dental implants cleared in K123022, and with the Universal Post Cylinders cleared in K101945. Equator Attachment CM abutments are straight, ball-type abutments for the attachment of overdentures or partial dentures. They are provided in five gingival heights (1.5, 2.5, 4.5 and 5.5 mm). These abutments have a titanium nitride (TiN) coating for the purpose of creating a harder surface to increase wear resistance. This titanium nitride coating is identical to that used on the Neodent CM Mini Ball Attachment cleared in K101945, and the Facility Equator Attachment cleared in K123022. Equator Attachment CM abutments are compatible with Titamax CM, Titamax CM EX, and Alvim CM implants cleared in K101945, and with the CM Drive implants cleared in K123022. All abutments in this submission are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
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, K101945 JJGC Indústria e Comércio de Materiais Dentários SA, Neodent Implant System, K123022
The subject device and the predicate devices have intended use, have similar technological characteristics, have similar designs and dimensions, use the same materials and the same surface treatment (titanium nitride) as abutments cleared under K101945 and K123022. The subject device and predicate devices encompass the same range of physical dimensions, including prosthetic height, gingival height, platform diameter, and angulation (straight). The subject and predicate devices are packaged in the same materials and sterilized using the same methods.
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility, engineering analysis and dimensional analysis. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above. Clinical data were not submitted in this premarket notification.
The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.
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Image /page/2/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes extending from its wing, symbolizing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircles the eagle, indicating the department's name and country.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 25, 2014
JJGC Indústria e Comércio de Materiais Dentários SA C/O Dr. Kevin Thomas Regulatory Consultant 12264 El Camino Real, Suite 400 San Diego, CA 92130
Re: K133696
Trade/Device Name: Neodent Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 3, 2014 Received: February 4, 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.
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
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Page 2 - Ms. Cheng
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/ReportalProblem/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/3/Picture/6 description: The image shows the name "Kwame O. Ulmer" in a bold, sans-serif font. Below the name, there is some additional text that is difficult to read due to its small size and the image quality. The text appears to be related to the letters "FDA", but the details are unclear.
for
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
Enclosure
4
510(k) Summary
Neodent Implant System
Indications for Use
KI33696 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)
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Sean Runner
Mary S. Runner -5
POS 04 291462.25
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