(137 days)
No
The document describes a dental implant system and its components, focusing on materials, dimensions, and intended use. There is no mention of AI or ML technology in the description, intended use, or performance studies.
Yes
The device is intended to restore chewing function by supporting prosthetic devices, which is a therapeutic purpose.
No
This device is an implantable dental system designed to provide support for prosthetic devices, restoring chewing function. It is a treatment device, not a diagnostic one.
No
The device description clearly details physical components made of titanium and titanium alloy, intended for surgical implantation. There is no mention of software as the primary or sole component.
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 bone to support prosthetic devices and restore chewing function. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the materials, design, and dimensions of dental implants and abutments. These are physical components for surgical implantation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.
The device is a dental implant system, which falls under the category of medical devices used for surgical and restorative purposes.
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.
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 purpose of this submission is to expand the Neodent Implant System components cleared under K101945, K123022, and K133592; these submissions included dental implants with a Morse taper (CM) abutment interface, mating abutments, abutment screws, and other associated components. The additions included in this submission are CM Alvim Acqua and Facility Acqua implants, and 17° angled anatomic abutments.
All of the subject device implants are threaded, self-tapping, root form, endosseous dental implants with Morse taper abutment interfaces. The CM Alvim Acqua implants are made from unalloyed titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloved Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700). The Facility Acqua implants are made from titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). All implants have the "Acqua" surface cleared in K133592. The Acqua surface begins with the traditional grit blasted and acid etched endosseous surface (branded "NeoPoros"), which is identical to that used on implants cleared in K101945 and K123022. The NeoPoros surface undergoes additional processing that renders the surface hydrophilic. The CM Alvim Acqua implants are provided in 3.5, 4.3, and 5.0 mm diameters: each diameter is provided in 8, 10, 11.5, 13. and 16 mm lengths. The Facility Acqua implant is provided with a 2.9 mm diameter in 8, 10, 12, 14, and 16 mm lengths.
This submission includes four series of cement-retained abutments intended for single unit prostheses in the esthetic zone. Each series has scalloped margins to follow the gingival contour to provide better esthetic results with the final prosthesis. The series include CM Anatomic and CM Lateral Anatomic abutments, each without and with an internal indexing feature (branded "Exact") at the apical end of the Morse taper connection. All abutments are angled 17°, are provided in 1.5, 2.5, and 3.5 mm gingival heights, and 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
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. Animal histology data were presented comparing predicate devices to the subject devices implanted in sheep tibiae.
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.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 15, 2015
JJGC Industria E Comercio De Materiais Dentarios SA c/o Kevin A. Thomas, Ph.D. PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K150199 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: May 13, 2015 Received: May 14, 2015
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.
1
Page 2 - Kevin A. Thomas, Ph.D.
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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K150199
Device Name
Neodent Implant System
Indications for Use (Describe)
CM Alvim Acqua Implant
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.
Facility Acqua Implant
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.
The Facility implant is indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures.
CM Anatomic Abutment, Exact Anatomic, Lateral Anatomic, and Lateral Anatomic Abutments
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K150199 510(k) Summary
JJGC Indústria e Comércio de Materiais Dentários SA
Neodent Implant System
May 13, 2015
ADMINISTRATIVE INFORMATION
| Manufacturer Name | JJGC Indústria e Comércio de Materiais Dentários S
Av. Juscelino Kubitschek de Oliveira, 3291 - CIC
Curitiba, Paraná, 81270-200, Brazil
Telephone: +55 41 2169 4058
Fax: +55 41 2169 1043 | |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Official Contact | Jacson Cambruzzi
Head of Quality and Regulatory Affairs | |
| 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, Class II |
| Product Code | DZE |
| NHA | |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
4
INTENDED USE
CM Alvim Acqua Implant
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.
Facility Acqua Implant
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 Facility implant is indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures.
CM Anatomic Abutment, Exact Anatomic, Lateral Anatomic, and Lateral Anatomic Abutments 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.
DEVICE DESCRIPTION
The purpose of this submission is to expand the Neodent Implant System components cleared under K101945, K123022, and K133592; these submissions included dental implants with a Morse taper (CM) abutment interface, mating abutments, abutment screws, and other associated components. The additions included in this submission are CM Alvim Acqua and Facility Acqua implants, and 17° angled anatomic abutments.
All of the subject device implants are threaded, self-tapping, root form, endosseous dental implants with Morse taper abutment interfaces. The CM Alvim Acqua implants are made from unalloyed titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloved Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700). The Facility Acqua implants are made from titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). All implants have the "Acqua" surface cleared in K133592. The Acqua surface begins with the traditional grit blasted and acid etched endosseous surface (branded "NeoPoros"), which is identical to that used on implants cleared in K101945 and K123022. The NeoPoros surface undergoes additional
5
processing that renders the surface hydrophilic. The CM Alvim Acqua implants are provided in 3.5, 4.3, and 5.0 mm diameters: each diameter is provided in 8, 10, 11.5, 13. and 16 mm lengths. The Facility Acqua implant is provided with a 2.9 mm diameter in 8, 10, 12, 14, and 16 mm lengths.
This submission includes four series of cement-retained abutments intended for single unit prostheses in the esthetic zone. Each series has scalloped margins to follow the gingival contour to provide better esthetic results with the final prosthesis. The series include CM Anatomic and CM Lateral Anatomic abutments, each without and with an internal indexing feature (branded "Exact") at the apical end of the Morse taper connection. All abutments are angled 17°, are provided in 1.5, 2.5, and 3.5 mm gingival heights, and are made from titanium alloy conforming to ASTM F136.
PERFORMANCE DATA
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility, engineering analysis, and dimensional analysis. Animal histology data were presented comparing predicate devices to the subject devices implanted in sheep tibiae.
Clinical data were not submitted in this premarket notification.
EQUIVALENCE TO MARKETED DEVICE
Neodent Implant System is substantially equivalent in indications and design principles to the following legally marketed predicate devices:
K133592, Neodent Implant System, Neodent USA, Inc.;
K101945, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários SA; and
K123022. Neodent Implant System. JJGC Indústria e Comércio de Materiais Dentários SA.
The primary predicate device is K123022. Reference predicates are K133492 and K101945.
The implants in this submission have similar designs and dimensions, use the same materials, and have the same surface as those cleared under K133592. K101945. and K123022. The CM Alvim Acqua implant design is identical to the design of the Alvim CM implant cleared in K101945. The Facility Acqua implant design is identical to the design of the Facility implant cleared in K123022. The Acqua surface treatment is identical to that cleared in K133592.
The abutments in this submission have similar designs and are made from the same material as those cleared under K101945 and K123022.
6
The subject device implant and abutments have similar packaging and are sterilized using the same processes as described in K133592, K101945, and K123022.
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 questions of safety or effectiveness.
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.