(119 days)
No
The document describes dental implants and abutments, focusing on materials, dimensions, and mechanical properties. There is no mention of AI or ML technology.
No
Dental implants and their associated components, like abutments, are considered restorative devices that support prosthetic structures, not therapeutic devices that treat a disease or condition.
No
Explanation: The device is an implant system (dental implants, abutments, and associated components) intended for surgical placement in the jaw bone to support prosthetic devices and restore chewing function. It does not perform any diagnostic function.
No
The device description clearly details physical components made of Co-Cr alloy and titanium alloy, which are hardware.
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 the bone to support prosthetic devices and restore chewing function. This is a direct therapeutic and restorative function within the body.
- Device Description: The description details physical components (implants, abutments, screws) made of materials like Co-Cr alloy and titanium alloy, designed for mechanical support and attachment of prosthetics.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. The device itself is implanted and functions mechanically.
Therefore, the Neodent Implant System and its components described are medical devices, but they do not fit the definition of 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.
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 - GM Line components cleared under K163194, which included dental implants with a Morse taper abutment interface (called Grand Morse, or GM), mating abutment screws, and other associated components. This submission includes the GM Exact Co-Cr Abutment for Crown and the GM Equator Attachment. The subject device components mate exclusively with the GM implants cleared in K163194.
The GM Exact Co-Cr Abutment for Crown is provided in three sizes to fit the prosthetic diameter sizes of the GM implants cleared in K163194. The subject device abutments consist of a Co-Cr alloy component that interfaces directly to the implant and a cvlinder of polyoxymethylene (POM) for fabrication of a cast prosthesis by a burn-out technique. The subject device abutments are provided in three (3) sizes to match the various platforms of the mating GM implants: 3.5/3.75 mm platform diameter, 4.0/4.3 mm platform diameter, and 5.0/6.0 mm platform diameter. The subject device abutments are for single-unit prosthetic restorations only. The final prosthetic restoration may be cement-retained or screw-retained.
The GM Equator Attachment abutments are straight, ball-type abutments for the attachment of full or partial overdentures. GM Equator Attachments are provided in five gingival heights (1.5, 2.5, 3.5, 4.5, and 5.5 mm), and may be used with all GM implant diameter sizes cleared in K163194.
The subject device GM Exact Co-Cr abutments are made of Co-Cr alloy conforming to ASTM F1537, with mating abutment screws made of titanium alloy conforming to ASTM F136. The GM Equator Attachments made of titanium alloy conforming to ASTM F136 with a TiN coating identical to the TiN coating cleared in K133696.
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 to demonstrate substantial equivalence include biocompatibility testing of the subject device GM Exact Co-Cr Abutment for Crown according to ISO 10993-5, ISO 10993-12 and ISO 10993-18. Non-clinical data relied upon to demonstrate substantial equivalence with regard to biocompatibility of titanium alloy components were incorporated by reference to K163194 and K133696. Sterilization validation testing of subject devices was performed according to ISO 17665-1. ISO TS 17665-2, ISO 11135, and ISO 10993-7. Sterile barrier shelf life testing was performed on real time aged samples (referenced from K163194) and included seal strength testing, helium leak detection, and sterility testing of the package contents. Bacterial endotoxin testing was performed using methods described in AAMI / ANSI ST72. 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
§ 872.3630 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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
JJGC Industria e Comercio de Materiais Dentarios S.A. Kevin Thomas Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
April 20, 2018
Re: K173902
Trade/Device Name: Neodent Implant System - GM Line Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: March 22, 2018 Received: March 22, 2018
Dear Kevin 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 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mary S. Runner -S
For Tina Kiang, Ph.D. Acting 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)
Device Name
Neodent Implant System - GM Line
Indications for Use (Describe)
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) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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510(k) Summary
K173902
Neodent Implant System - GM Line
JJGC Indústria e Comércio de Materiais Dentários SA
April 18, 2018
ADMINISTRATIVE INFORMATION
| 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 1000 | |
| | Fax: | +55 41 2169 4061 | |
| Official Contact | Julianne de Oliveira Capucho Lechechem
Regulatory Affairs Manager | | |
| Representative/Consultant | Kevin A. Thomas, PhD
Floyd G. Larson, MS, MBA
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 | flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | Neodent Implant System - GM Line |
|---|---|
| Common Name | 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 |
PREDICATE DEVICE INFORMATION
The primary predicate device is K163194. The reference predicate devices are K101207, K121843, and K133696.
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.
4
SUBJECT DEVICE DESCRIPTION
The purpose of this submission is to expand the Neodent Implant System - GM Line components cleared under K163194, which included dental implants with a Morse taper abutment interface (called Grand Morse, or GM), mating abutment screws, and other associated components. This submission includes the GM Exact Co-Cr Abutment for Crown and the GM Equator Attachment. The subject device components mate exclusively with the GM implants cleared in K163194.
The GM Exact Co-Cr Abutment for Crown is provided in three sizes to fit the prosthetic diameter sizes of the GM implants cleared in K163194. The subject device abutments consist of a Co-Cr alloy component that interfaces directly to the implant and a cvlinder of polyoxymethylene (POM) for fabrication of a cast prosthesis by a burn-out technique. The subject device abutments are provided in three (3) sizes to match the various platforms of the mating GM implants: 3.5/3.75 mm platform diameter, 4.0/4.3 mm platform diameter, and 5.0/6.0 mm platform diameter. The subject device abutments are for single-unit prosthetic restorations only. The final prosthetic restoration may be cement-retained or screw-retained.
The GM Equator Attachment abutments are straight, ball-type abutments for the attachment of full or partial overdentures. GM Equator Attachments are provided in five gingival heights (1.5, 2.5, 3.5, 4.5, and 5.5 mm), and may be used with all GM implant diameter sizes cleared in K163194.
The subject device GM Exact Co-Cr abutments are made of Co-Cr alloy conforming to ASTM F1537, with mating abutment screws made of titanium alloy conforming to ASTM F136. The GM Equator Attachments made of titanium alloy conforming to ASTM F136 with a TiN coating identical to the TiN coating cleared in K133696.
PERFORMANCE DATA
Non-clinical data submitted to demonstrate substantial equivalence include biocompatibility testing of the subject device GM Exact Co-Cr Abutment for Crown according to ISO 10993-5, ISO 10993-12 and ISO 10993-18. Non-clinical data relied upon to demonstrate substantial equivalence with regard to biocompatibility of titanium alloy components were incorporated by reference to K163194 and K133696. Sterilization validation testing of subject devices was performed according to ISO 17665-1. ISO TS 17665-2, ISO 11135, and ISO 10993-7. Sterile barrier shelf life testing was performed on real time aged samples (referenced from K163194) and included seal strength testing, helium leak detection, and sterility testing of the package contents. Bacterial endotoxin testing was performed using methods described in AAMI / ANSI ST72. Clinical data were not submitted in this premarket notification.
EQUIVALENCE TO MARKETED DEVICES
JJGC Indústria e Comércio de Materiais Dentários S.A. submits the information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the subject device is substantially equivalent in indications and design principles to the following legally marketed predicate devices:
K163194, Neodent Implant System - GM Line, JJGC Indústria e Comércio de Materiais Dentários S.A.;
K101207, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A.;
K121843, NP-Cast Abutment System, OSSTEM Implant Co., Ltd.; and
K133696, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A.
A comparison of the Indications for Use and the technological characteristics of the subject device and the primary predicate device K163194 is provided in the following table.
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| Subject Device | Primary Predicate Device | |
|---|---|---|
| Comparison | Neodent Implant System - GM Line | |
| JJGC Indústria e Comércio de Materiais Dentários S.A. | K163194 | |
| Neodent Implant System - GM Line | ||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | ||
| Indications for Use | ||
| Statement | 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. | Indications for Use for GM implants and conventional | |
| 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. | ||
| Indications for Use for GM Titanium Base abutments: | ||
| 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. All digitally | ||
| designed copings and/or crowns for use with the Neodent | ||
| Titanium Base Abutment System are intended to be sent to | ||
| Straumann for manufacture at a validated milling center. | ||
| Indications for Use for GM Pro Peek Abutments: | ||
| The Pro PEEK Abutments are indicated to be used on Neodent | ||
| implants to provide temporary support for prosthesis structure | ||
| for up to 6 months. They can be used in one or two stage | ||
| procedures and also immediate load when there is good primary | ||
| stability. | ||
| Product Code | NHA | DZE, NHA |
| Intended Use | Functional and esthetic rehabilitation of the edentulous | |
| mandible or maxilla | Functional and esthetic rehabilitation of the edentulous | |
| mandible or maxilla | ||
| Design | ||
| Implant Design | Threaded root-form implants, 3 thread designs; | |
| Internal Morse taper abutment connection | ||
| Implant Diameter | Not applicable | Various, 3.5 mm to 5.0 mm |
| Implant Length | Various, 7 mm to 18 mm | |
| Abutment Design | GM Exact Co-Cr Abutment for Crown: | |
| Component for cast-to fabrication | ||
| GM Equator Attachment: | ||
| Ball-type for partial or full overdentures | Healing; temporary; conventional 1-piece, | |
| 2-piece, CAD-CAM | ||
| Gingival Height | GM Exact Co-Cr Abutment for Crown: 1.0 mm | |
| GM Equator Attachment: 1.5, 2.5, 3.5, 4.5, 5.5 mm | 0.8 mm to 5.5 mm | |
| Implant-Abutment | ||
| Platform Diameter | Exact Co-Cr Abutment for Crown: To match GM | |
| implant diameters 3.5/3.75, 4.0/4.3, and 5.0/6.0 | ||
| GM Equator Attachment: Fits all GM implants | To match implant diameters | |
| Prosthesis Attachment | Exact Co-Cr Abutment for Crown: | |
| Cement-retained, screw-retained | ||
| GM Equator Attachment: | ||
| Ball-type for partial or full overdentures | Cement-retained and screw-retained | |
| Restoration | Exact Co-Cr Abutment for Crown: Single-unit | |
| GM Equator Attachment: Multi-unit | Single-unit and multi-unit | |
| Abutment Angle | None (straight 0° only) | None (straight 0°), 17°, 30° |
| Abutment-Implant Interface | Exact Co-Cr Abutment for Crown: | |
| Morse taper (GM Line) | ||
| GM Equator Attachment: Morse taper (GM Line) | Morse taper (GM Line) | |
| Materials | ||
| Abutment | Exact Co-Cr Abutment for Crown: | |
| Co-Cr-Mo alloy, ASTM F1537 | ||
| GM Equator Attachment: | ||
| Ti-6Al-4V alloy, ASTM F136, with TiN coating | Ti-6Al-4V alloy, ASTM F136; PEEK | |
| Abutment Screw | Exact Co-Cr Abutment for Crown: | |
| Ti-6Al-4V alloy, ASTM F136 | ||
| GM Equator Attachment: Not applicable | Ti-6Al-4V alloy, ASTM F136 | |
| Comparison | Subject Device | Primary Predicate Device |
| Neodent Implant System – GM Line | ||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | K163194 | |
| Neodent Implant System – GM Line | ||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | ||
| How Provided | ||
| Exact Co-Cr Abutment for Crown: Non-sterile | ||
| Sterility/Sterilization | GM Equator Attachment: | |
| Sterile by ethylene oxide exposure | Abutments: Sterile by ethylene oxide exposure | |
| Usage | Single-patient, single-use | Single-patient, single-use |
6
The primary predicate device K163194 is for substantial equivalence of the subject device abutmentimplant interface design. The subject device abutments have the identical implant interface design and are to mate exclusively with the Neodent GM implants cleared in K163194. The subject device abutments and abutments cleared in K163194 are provided in straight (0°) designs with internal hex prosthetic indexing and titanium alloy abutment screws. The differences between the subject device abutments and the abutments cleared in K163194 are the addition of the cast-to design and the Co-Cr alloy material.
The reference predicate device K101207 is for substantial equivalence of the design of the cast-to, UCLA-type abutment. K10107 included cast-to, UCLA-type abutments consisting of a titanium alloy component that interfaces directly to the implant and a POM burn-out sleeve for fabrication of a cast abutment. The differences between the subject device abutments and the abutments cleared in K 101207 are the implant interface and the Co-Cr alloy material.
The reference predicate device K121843 is for substantial equivalence of the cast-to, UCLA-type abutment design consisting of a Co-Cr alloy component that interfaces directly to the implant and a POM burn-out sleeve for fabrication of a cast abutment. The subject device abutments and the abutments cleared in K121843 include Morse taper connections with internal hex indexing. The primary difference between the subject device abutments and the abutments cleared in K121843 is the implant interface.
The Indications for Use Statements for the subject device and primary predicate device K163194 are similar, with the language that the subject device abutments are for support of prosthetic restorations. The intended use of the subject device abutments is similar to that of the abutments in each of the predicate devices. The slight differences in wording among the Indications for Use Statements for the subject device and the predicate devices reflects the fact that the predicate submissions include components, such as CAD/CAM abutments, that are not included in the subject submission. The differences do not affect the intended use with dental implants for rehabilitation of the edentulous maxilla or mandible.
CONCLUSION
The subject device and the predicate devices have the same intended use, have similar technological characteristics, and are made of the same or similar materials. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.