(231 days)
K 101945, K 070601, K 080598, K 073343, K 092594, K 081653, K 050712, and K 0 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8
No
The device description and intended use focus on the physical characteristics and function of dental implants and abutments. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are non-clinical engineering analyses.
Yes
The device is described as an implant system intended to provide support for prosthetic devices to restore chewing function, which addresses a health-related condition (loss of chewing function).
No
This device is a dental implant system designed to provide support for prosthetic devices (artificial teeth) to restore chewing function. It is a therapy device, not a diagnostic one, as it does not perform any diagnostic function such as identifying, screening, or monitoring a disease or condition.
No
The device description clearly details physical components made of titanium and titanium alloy, which are hardware.
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 such as artificial teeth, to restore chewing function." This describes a surgical implant used for structural support, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The description details a physical implant made of titanium, designed to be placed in bone. This is consistent with a surgical device, not an IVD.
- Lack of IVD characteristics: The description does not mention any reagents, calibrators, controls, or any other components typically associated with in vitro diagnostic tests. It also doesn't describe any process of analyzing biological samples.
In summary, the Neodent Implant System is a surgical dental 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.
Titamax WS implant is indicated for a delayed loading protocol.
The Facility implant is indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The Neodent Implant System implants included in this submission are threaded, self-tapping, root form, endosseous dental implants with a Morse taper abutment interface. They are designed to provide support for prosthetic teeth to restore chewing function. They are made of commercially pure titanium or titanium alloy, with a surface that is grit blasted and acid etched. In addition, multiple abutments made of titanium alloy are provided for each implant for both cement-retained and screw-retained prostheses. The CM Drive implant comes in three diameters (3.5, 4.3 and 5.0 mm), each in five lengths (8.0, 10.0, 11.5, 13.0, and 16.0 mm). The Titamax WS implant design comes in three diameters (4.0, 5.0, and 6.0 mm) with corresponding platform diameters. The 4.0 mm diameter Titamax WS implant comes in one length (6.0 mm). The 5.0 and 6.0 mm diameter Titamax WS implants come in two lengths (5.0 and 6.0 mm). The Facility implant design comes in one diameter (2.9 mm), and in five lengths (8, 10, 12, 14, and 16 mm). All abutments included in this submission are straight and have a Morse taper connection.
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, maxillary lateral incisors, mandibular incisors
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: engineering analysis, dimensional analysis and comparative surface area 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.
K 101945, K 070601, K 080598, K 073343, K 092594, K 081653, K 050712, and K 0 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8
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.
K092035, K050712, K010185, K070601, K080598, K073343, K092594, K081653
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
510(k) Summary
Neodent Implant System
510(k) Summary
MAY 1 7 2013
JJGC Indústria e Comércio de Materiais Dentários SA Neodent Implant System
K123022
May 6, 2013
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 Telephone: +55 41 2169 4071 +55 41 2169 4041 Fax:
Official Contact
Representative/Consultant
Daniel Lecuona General Manager
Allison C. Komiyama, Ph.D. Linda K. Schulz, BSDH, RDH PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: +1 (858) 792-1235 +1 (858) 792-1236 Fax: akomiyama@paxmed.com Email: lschulz@paxmed.com
DEVICE NAME AND CLASSIFICATION
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 . DZE NHA Dental Products Panel Dental Devices Branch
1
510(k) Summary
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.
Titamax WS implant is indicated for a delayed loading protocol.
The Facility implant is indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures.
DEVICE DESCRIPTION
The Neodent Implant System implants included in this submission are threaded, self-tapping, root form, endosseous dental implants with a Morse taper abutment interface. They are designed to provide support for prosthetic teeth to restore chewing function. They are made of commercially pure titanium or titanium alloy, with a surface that is grit blasted and acid etched. In addition, multiple abutments made of titanium alloy are provided for each implant for both cement-retained and screw-retained prostheses. The CM Drive implant comes in three diameters (3.5, 4.3 and 5.0 mm), each in five lengths (8.0, 10.0, 11.5, 13.0, and 16.0 mm). The Titamax WS implant design comes in three diameters (4.0, 5.0, and 6.0 mm) with corresponding platform diameters. The 4.0 mm diameter Titamax WS implant comes in one length (6.0 mm). The 5.0 and 6.0 mm diameter Titamax WS implants come in two lengths (5.0 and 6.0 mm). The Facility implant design comes in one diameter (2.9 mm), and in five lengths (8, 10, 12, 14, and 16 mm). All abutments included in this submission are straight and have a Morse taper connection.
EQUIVALENCE TO MARKETED DEVICE
The subject device is substantially equivalent to the following predicate devices: K 101945, K 070601, K 080598, K 073343, K 092594, K 081653, K 050712, and K 0 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8
The Neodent Implant System expands the currently cleared system to include new designs of implants and their corresponding cement- or screw-retained abutments. The implants of the subject Neodent Implant System have a similar design, identical material and identical surface as those cleared under K 101945. The new Titamax WS implant is similar in indications, design and dimensions to the Bicon devices cleared in K092035, K050712, and K010185. The new Facility implant is similar in indications, design and dimensions to the Intra-Lock devices cleared in K070601 and K080598, the Ace Surgical Supply devices cleared in K073343 and K092594, and the IMTEC Corporation devices cleared in K081653. The abutments of the subject Neodent Implant System have a similar design and identical material as those cleared under K101945.
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: engineering analysis, dimensional analysis and comparative surface area 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.
2
510(k) Summary
CONCLUSIONS
The subject device and the predicate devices have the same intended use, have the same technological characteristics, and are made of the same 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.
3
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 17, 2013
JJGC Indústria e Comércio de Materiais Dentários SA C/O Allison C. Komiyama Ph.D. Senior Regulatory Specialist PaxMed International, Limited Liability Company 11234 El Camino Real. Suite 200 SAN DIEGO CA 92130
Re: K123022
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: April 18, 2013 Received: April 19, 2013
Dear Dr. Komiyama:
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. Komiyama
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 devicerelated 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 vours.
Kwame O. Ulmer -S for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital,
Respiratory, Infection Control and
Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: 1123022
Device Name: Neodent Implant System
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.
Titamax WS implant is indicated for a delayed loading protocol.
The Facility implant is indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures.
Prescription Use × (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 Ision Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Division of Antost. Dental Devices 510(k) Number