(151 days)
No
The device description and performance studies focus on the mechanical properties and compatibility of dental abutments, with no mention of AI or ML.
No
The device is an abutment for dental implants, providing support for prosthetic restorations, which is a structural component rather than a device intended to treat or cure a disease or condition.
No
The device is a titanium abutment used to support prosthetic restorations on dental implants. It is a structural component, not something that diagnoses a condition.
No
The device description clearly states that the device is a physical titanium abutment, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to provide support for customized prosthetic restorations placed onto dental implants. This is a structural and mechanical function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the materials, dimensions, and compatibility with dental implants. It focuses on the physical characteristics and function of the abutments in supporting dental prosthetics.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
The device is clearly a dental prosthetic component used in the treatment of tooth loss, not a diagnostic tool.
N/A
Intended Use / Indications for Use
Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations.
PreFace Abutment is a titanium abutment to be used in fabricating a full custom abutment and placed onto Neodent dental implants to provide support for customized prosthetic restorations. PreFace Abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations.
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, K123022, and K133592; these submissions included dental implants with a Morse taper abutment interface, mating abutments, abutment screws, and other associated components. This submission includes the Titanium Base Abutment, provided in two prosthetic platform diameters (3.5 and 4.5 mm), each in five gingival heights (0.8, 1.5, 2.5, 3.5 and 4.5 mm). Titanium Base is an abutment to be used as a base when fabricating a zirconia superstructure. This submission also includes the PreFace Abutment in two overall (milling) diameters of 11.5 and 15.8 mm. The PreFace Abutment with overall (milling) diameter of 15.8 mm is only used to mill an angled abutment.
PreFace is an abutment to be used in fabricating a full custom abutment in titanium alloy. After milling the minimum wall thickness for the PreFace must be no less than 0.4 mm, and the emergence profile diameter must be at least 3.3 mm. The maximum limit for angulation is 30°, and the maximum gingival height is 6 mm from the implant platform. In the case of an angled abutment, the cementable height from the emergence profile (prosthetic height) must not exceed 6 mm. The total height of the abutment (above the implant-abutment connection platform) must be no greater than 14.2 mm and no shorter than 4 mm. The range for the abutment body diameter (above the implant-abutment connection platform) is 3.3 mm. The implant interface must remain intact and cannot be modified.
The subject abutments 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). The subject abutments are compatible with Neodent dental implants having the Morse taper interface cleared in K101945, K123022 and K133592.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dental
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. Mechanical testing was performed on the Titanium Base and PreFace abutments according to ISO 14801 Dentistry -Implants - Dynamic fatigue test for endosseous dental implants. Sterilization testing was performed according to ISO 17665-1 Sterilization of health care products - Moist heat -Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices and ISO 17665-2 Sterilization of health care products – Moist heat – Part 2: Guidance on the application of ISO 17665-1. Clinical data were not submitted in this premarket notification.
Mechanical test results demonstrated that the strengths of subject Titanium Base and PreFace abutments are equal to or greater than that of predicate abutments in K120822 and K133421, respectively.
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.
K120822, K052272, K133421, K133592, K123022, K101945
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.
K133421, K133592, K123022, K101945
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.)
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 13, 2015
Jjgc Industria E Comercio De Materiais Dentarios S c/o Mr. Kevin Thomas Paxmed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K150367
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: May 27, 2015 Received: May 28, 2015
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.
1
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,
lina 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) K150367
Device Name
Neodent Implant System
Indications for Use (Describe)
Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations.
PreFace Abutment is a titanium abutment to be used in fabricating a full custom abutment and placed onto Neodent dental implants to provide support for customized prosthetic restorations. PreFace Abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations.
Type of Use (Select one or both, as applicable)
|X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
JJGC Indústria e Comércio de Materiais Dentários SA
Neodent Implant System
July 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 abutment |
| Classification Name | Endosseous dental implant abutment |
| Classification Regulation | 21 CFR 872.3630, Class II |
| Product Code | NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
4
INTENDED USE
Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations.
PreFace Abutment is a titanium abutment to be used in fabricating a full custom abutment and placed onto Neodent dental implants to provide support for customized prosthetic restorations. PreFace Abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations.
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 abutment interface, mating abutments, abutment screws, and other associated components. This submission includes the Titanium Base Abutment, provided in two prosthetic platform diameters (3.5 and 4.5 mm), each in five gingival heights (0.8, 1.5, 2.5, 3.5 and 4.5 mm). Titanium Base is an abutment to be used as a base when fabricating a zirconia superstructure. This submission also includes the PreFace Abutment in two overall (milling) diameters of 11.5 and 15.8 mm. The PreFace Abutment with overall (milling) diameter of 15.8 mm is only used to mill an angled abutment.
PreFace is an abutment to be used in fabricating a full custom abutment in titanium alloy. After milling the minimum wall thickness for the PreFace must be no less than 0.4 mm, and the emergence profile diameter must be at least 3.3 mm. The maximum limit for angulation is 30°, and the maximum gingival height is 6 mm from the implant platform. In the case of an angled abutment, the cementable height from the emergence profile (prosthetic height) must not exceed 6 mm. The total height of the abutment (above the implant-abutment connection platform) must be no greater than 14.2 mm and no shorter than 4 mm. The range for the abutment body diameter (above the implant-abutment connection platform) is 3.3 mm. The implant interface must remain intact and cannot be modified.
The subject abutments 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). The subject abutments are compatible with Neodent dental implants having the Morse taper interface cleared in K101945, K123022 and K133592.
PERFORMANCE DATA
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility, engineering analysis, and dimensional analysis. Mechanical testing was performed on the Titanium Base and PreFace abutments according to ISO 14801 Dentistry -Implants - Dynamic fatigue test for endosseous dental implants. Sterilization testing was performed according to ISO 17665-1 Sterilization of health care products - Moist heat -Part 1: Requirements for the development, validation and routine control of a sterilization
5
process for medical devices and ISO 17665-2 Sterilization of health care products – Moist heat – Part 2: Guidance on the application of ISO 17665-1. 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:
K120822, Straumann® CARES® Variobase™ Abutments, Institut Straumann AG;
K052272, Straumann C.A.R.E.S. Titanium Abutment, Institut Straumann AG;
K133421, Straumann® Magellan™ Abutment System, Institut Straumann AG;
K133592, Neodent Implant System, Neodent USA, Inc .;
K 123022, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários SA , and
K101945, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários SA.
The primary predicate device for the Titanium Base abutment is K120822. The primary predicate device for the PreFace abutment is K052272. The reference predicate devices are K133421, K133592, K123022, and K101945. A comparison of the technological characteristics of the subject device and the primary predicate devices K120822 and K052272 is provided in the following table.
| Subject Device | Primary Predicate Devices | ||
|---|---|---|---|
| Comparison | JJGC Indústria e Comércio de | ||
| Materiais Dentários SA | |||
| Neodent Implant System | |||
| K150367 | Institut Straumann AG | ||
| Straumann® CARES® Variobase™ | |||
| Abutments | |||
| K120822 | Institut Straumann AG | ||
| Straumann C.A.R.E.S. Titanium | |||
| Abutment | |||
| K052272 | |||
| Indications for Use | Titanium Base Abutment is a | ||
| titanium base placed onto Neodent | |||
| dental implants to provide support | |||
| for customized prosthetic | |||
| restorations. It is indicated for | |||
| cement-retained single or multi-unit | |||
| restorations, or screw-retained | |||
| single restorations. | |||
| PreFace Abutment is a titanium | |||
| abutment to be used in fabricating a | |||
| full custom abutment and placed | |||
| onto Neodent dental implants to | |||
| provide support for customized | |||
| prosthetic restorations. PreFace | |||
| Abutments are indicated for screw- | |||
| retained single restorations or | |||
| cement-retained single or multi-unit | |||
| restorations. | The Straumann® CARES® | ||
| Variobase™ Abutment is a two- | |||
| piece dental abutment consisting of | |||
| the Straumann® Variobase™ | |||
| Abutment and the Straumann® | |||
| CARES® Variobase™ Coping | |||
| which is intended to be placed onto | |||
| Straumann dental implants to | |||
| provide support for prosthetic | |||
| reconstruction such as crowns and | |||
| bridges. Straumann® CARES® | |||
| Variobase™ Abutments are | |||
| indicated for screw-retained single | |||
| tooth or cement-retained single | |||
| tooth and bridge restorations. | |||
| The Straumann® CARES® | |||
| Variobase™ Coping polycon® ae in | |||
| combination with the Straumann® | |||
| Variobase™ Abutment is indicated | |||
| for temporary (up to 180 days) | |||
| dental restoration of a Straumann | |||
| dental implant. | Abutments are intended to be | ||
| placed into dental implants to | |||
| provide support for prosthetic | |||
| reconstructions such as crowns or | |||
| bridges. The Straumann C.A.R.E.S. | |||
| Titanium Abutment is indicated for | |||
| cemented restorations. The | |||
| abutment can be used in single | |||
| tooth replacements and multiple | |||
| tooth restorations. | |||
| Abutment Characteristics | |||
| Design | Titanium Base and | ||
| CAD/CAM Blank | Titanium Base | CAD/CAM Blank | |
| Prosthesis Attachment | Screw-retained | ||
| Cement-retained | Cement-retained | Cement-retained |
6
| Subject Device | Primary Predicate Devices | ||
|---|---|---|---|
| Comparison | JJGC Indústria e Comércio de | ||
| Materiais Dentários SA | |||
| Neodent Implant System | |||
| K150367 | Institut Straumann AG | ||
| Straumann® CARES® Variobase™ | |||
| Abutments | |||
| K120822 | Institut Straumann AG | ||
| Straumann C.A.R.E.S. Titanium | |||
| Abutment | |||
| K052272 | |||
| Restoration | Single-unit | ||
| Multi-unit | Single-unit | ||
| Multi-unit | Single-unit | ||
| Multi-unit | |||
| Abutment Diameter | Titanium Base: 3.5 and 4.5 mm | ||
| PreFace: 11.5 and 15.8 mm | |||
| (milling diameter) | 3.3 - 6.5 mm | 3.3 - 6.5 mm | |
| Abutment Angle | Up to 30° | Up to 30° | Up to 30° |
| Abutment/ Implant Interface | Indexed | Indexed, non-indexed | Indexed, non-indexed |
| Abutment Material | Ti-6Al-4V | Ti-6Al-7Nb | Ti-6Al-7Nb |
| Abutment Screw Material | Ti-6Al-4V | Ti-6Al-7Nb | Ti-6Al-7Nb |
The subject device and the primary predicate devices have substantially equivalent indications for use, including providing support for customized prosthetic restorations.
The subject Titanium Base abutments are substantially equivalent in design, function, size, and material to the Straumann CARES Variobase Abutments cleared in K120822. All are titanium alloy bonding bases for CAD/CAM zirconia superstructures. The scanning and designing software used for the zirconia superstructure is the Straumann CARES System (K120822). Final fabrication of the abutment will be done at the Straumann Milling Center. The subject PreFace abutments are substantially equivalent in design, function, size, and material to the Straumann C.A.R.E.S. Titanium Abutment cleared in K052272. Both are abutment blanks for CAD/CAM fabrication of a custom titanium alloy abutment. Each has a precision implant-abutment interface compatible with specific implant systems. The scanning and designing software used for the subject PreFace abutment is the Straumann CARES System (K052272). Final fabrication of the abutment will be done at the Straumann Milling Center.
Minor differences in the technological characteristics of the subject device and primary predicate devices include the option for screw-retained prosthesis attachment, the range of (finished) abutment diameters, the provision of only indexed implant interfaces for the subject devices, and slight differences in the device materials (Ti-6Al-4V for the subject devices and Ti-6A1-7Nb for the primary predicate devices).
Mechanical test results demonstrated that the strengths of subject Titanium Base and PreFace abutments are equal to or greater than that of predicate abutments in K120822 and K133421, respectively.
7
510(k) Summary K150367
CONCLUSION
Overall, the subject device 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 to be sterilized using the same processes. .
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.