(183 days)
No
The document describes dental implants and abutments, focusing on materials, dimensions, and mechanical properties. It mentions digital design and manufacturing (CAD/CAM) but does not indicate the use of AI or ML for tasks like image analysis, diagnosis, or treatment planning.
Yes
The Neodent Implant System is surgically placed in the jaw bone to support prosthetic devices for restoring chewing function, which is a therapeutic purpose.
No
The device description indicates it is a dental implant system and associated prosthetic components (implants, healing abutments, titanium blocks, and bases) used to support artificial teeth or restorations, not to diagnose a condition.
No
The device description clearly details physical components such as dental implants, abutments, and titanium blocks, which are hardware. While the device system involves digital design software (Sirona inLab, Sirona CEREC, Dental Wings Operating System, 3Shape), the core medical device being cleared consists of physical implants and abutments.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is surgically placed in the bone of the jaw to support prosthetic devices like artificial teeth. This is a surgical and prosthetic application, not a diagnostic test performed on samples outside the body.
- Device Description: The device description details implants, abutments, and components used to support dental prosthetics. It describes physical components for surgical implantation and prosthetic attachment.
- 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, etc.) to provide information for diagnosis, monitoring, or screening.
The device is a dental implant system and associated components, which are considered medical devices but not IVDs.
N/A
Intended Use / Indications for Use
Indications for Use for GM Helix 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 Exact Titanium Block for Medentika Holder:
GM Exact Titanium Block for Medentika Holder 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. The GM Exact Titanium Block for Medentika Holder abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. All digitally designed abutments for use with the GM Exact Titanium Block for Medentika Holder are intended to be sent to Straumann for manufacture at a validated milling center.
Indications for Use for GM Exact 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 Titanium Base C for GM Exact abutments:
The Titanium Base C for GM Exact abutments is a titanium component that is placed over Neodent implants to provide support for custom prosthetic restorations, such as copings or crowns. It is indicated for single-tooth screw-retained restorations. All digitally designed copings and/or crowns for use with the Titanium Base C for GM Exact abutments are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.
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 - 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: GM Helix Implant in diameter (6 mm), overall lengths of 8 mm to 13 mm, and in two endosseous surfaces, grit-blasted and acid etched (NeoPoros) and hydrophilic surface (Acqua); GM Customizable Healing Abutment in two prosthetic diameters (5.5 mm and 7.0 mm), each in multiple gingival heights (ranging from 1.5 mm to 6.5 mm); GM Exact Titanium Block for Medentika Holder titanium blank abutment, in two milling diameters, 11.5 mm and 15.8 mm; GM Exact Titanium Base in one prosthetic diameter (5.5 mm), six gingival heights (from 0.8 mm to 5.5 mm), and two prosthetic post heights (4 mm and 6 mm); and Titanium Base C for GM Exact one prosthetic diameter (4.65 mm), 6 gingival heights (from 0.8 mm to 5.5 mm), and one prosthetic post height (4.7 mm).
The GM Exact Titanium Base and Titanium Base C for GM Exact are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis; the GM Exact Titanium Base and Titanium Base C for GM Exact are two piece abutments used as a base when fabricating a CAD/CAM customized restoration. The GM Exact Titanium Base C for GM Exact are provided in an anti-rotational shape for the coupling with the prosthesis and are available in diameters of 4.65 mm (Titanium Base C for GM Exact) and 5.5 mm (GM Exact Titanium Base), and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 mm. The planning and milling of the customized superstructures must be made using the validated Dental Wings Operating System (DWOS) or 3Shape software. All digitally designed copings and/or crowns for use with the GM Exact Titanium Base and Titanium Base C for GM Exact are intended to be manufactured at a validated milling center. The limits for customization are stated in the GM Exact Titanium Base and Titanium Base C for GM Exact product IFU. The superstructure produced through CAD/CAM System will compose the second part of the two-piece abutment; the assembly becomes a finished medical device after cementation on the GM Exact Titanium Base or Titanium Base C for GM Exact. The GM Exact Titanium Base is indicated for screw-retained single-unit, or cement-retained single or multi-unit prosthesis attachment onto implants. The Titanium Base C for GM Exact is indicated for cement-retained single-unit prosthesis attachment onto implants.
The subject device abutments components mate exclusively with the GM implants cleared in K163194.
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 included: sterilization validation according to ISO 11137-1, ISO 11137-2. ISO 11135, ISO 10993-7, ISO 17665-1, ISO 17665-2, and ISO 11135 10993-7 (referenced from K163194); bacterial endotoxin according to AAMI/ANSI ST72 (referenced from K163194); sterile barrier shelf life testing (accelerated aging according to ASTM F1980; seal integrity according to ASTM E499/E499M and ASTM F1929; seal strength according to ASTM F88/F88M; and sterility of the package contents according to ISO 11737, all referenced from K163194); biocompatibility (referenced from K163194); engineering analysis; dimensional analysis; and static and dynamic compression-bending to ISO 14801. Clinical data were not submitted in this premarket notification.
In support of substantial equivalence in terms of mechanical performance, dynamic compression-bending testing was performed according to ISO 14801 on worst-case subject device constructs. The results from the testing demonstrated fatigue performance of the subject device GM Exact Titanium Base to be substantially equivalent to that of the predicate device K163194.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 30, 2018
JJGC Indústria e Comércio de Materiais Dentários S.A. % Kevin Thomas Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K180536
Trade/Device Name: Neodent Implant System - GM Line Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: August 6, 2018 Received: August 7, 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions 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 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,
Andrew I. Steen -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)
K180536
Device Name
Neodent Implant System - GM Line
Indications for Use (Describe)
Indications for Use for GM Helix 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 attificial 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 Exact Titanium Block for Medentika Holder:
GM Exact Titanium Block for Medentika Holder is a titanium abutment to be used in fabricating a full custom and placed onto Neodent dental implants to provide support for customized prosthetic restorations. The GM Exact Titanium Block for Medentika Holder abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. All digitally designed abutments for use with the GM Exact Titanium Block for Medentika Holder are intended to be sent to Straumann for manufacture at a validated milling center.
Indications for Use for GM Exact 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 alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations. All digitally designed copins 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 Titanium Base C for GM Exact abutments:
The Titanium Base C for GM Exact abutments is a titanium component that is placed over Neodent implants to provide support for custom prosthetic restorations, such as copins. It is indicated for single-tooth screw-retained restorations. All digitally designed copings and/or crowns for use with the Titanium Base C for GM Exact abutments are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.
Type of Use (Select one or both, as applicable)
|X | Prescription Use (Part 21 CFR 801 Subpart D)
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."
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
EF
PSC Publishing Services (301) 443-6740
3
510(k) Summary K180536
Neodent Implant System - GM Line JJGC Indústria e Comércio de Materiais Dentários SA
August 29, 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 4000 | | |
| | 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 and abutment |
| Classification Name | Endosseous dental implant |
| Classification Regulation | 21 CFR 872.3640 |
Device Class Product Codes Class II DZE, NHA
Classification Panel Dental Products Panel Reviewing Branch Dental Devices Branch
PREDICATE DEVICE INFORMATION
The primary predicate device is K163194. The reference devices are K123022, K160964, and K150367.
INDICATIONS FOR USE
Indications for Use for GM Helix 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.
4
Indications for Use for GM Exact Titanium Block for Medentika Holder:
GM Exact Titanium Block for Medentika Holder 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. The GM Exact Titanium Block for Medentika Holder abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. All digitally designed abutments for use with the GM Exact Titanium Block for Medentika Holder are intended to be sent to Straumann for manufacture at a validated milling center.
Indications for Use for GM Exact 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 Titanium Base C for GM Exact abutments:
The Titanium Base C for GM Exact abutments is a titanium component that is placed over Neodent implants to provide support for custom prosthetic restorations, such as copings or crowns. It is indicated for single-tooth screw-retained restorations.
All digitally designed copings and/or crowns for use with the Titanium Base C for GM Exact abutments are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.
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: GM Helix Implant in diameter (6 mm), overall lengths of 8 mm to 13 mm, and in two endosseous surfaces, grit-blasted and acid etched (NeoPoros) and hydrophilic surface (Acqua); GM Customizable Healing Abutment in two prosthetic diameters (5.5 mm and 7.0 mm), each in multiple gingival heights (ranging from 1.5 mm to 6.5 mm); GM Exact Titanium Block for Medentika Holder titanium blank abutment, in two milling diameters, 11.5 mm and 15.8 mm; GM Exact Titanium Base in one prosthetic diameter (5.5 mm), six gingival heights (from 0.8 mm to 5.5 mm), and two prosthetic post heights (4 mm and 6 mm); and Titanium Base C for GM Exact one prosthetic diameter (4.65 mm), 6 gingival heights (from 0.8 mm to 5.5 mm), and one prosthetic post height (4.7 mm).
The GM Exact Titanium Base and Titanium Base C for GM Exact are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis; the GM Exact Titanium Base and Titanium Base C for GM Exact are two piece abutments used as a base when fabricating a CAD/CAM customized restoration. The GM Exact Titanium Base C for GM Exact are provided in an anti-rotational shape for the coupling with the prosthesis and are available in diameters of 4.65 mm (Titanium Base C for GM Exact) and 5.5 mm (GM Exact Titanium Base), and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 mm. The planning and milling of the customized superstructures must be made using the validated Dental Wings Operating System (DWOS) or 3Shape software. All digitally designed copings and/or crowns for use with the GM Exact Titanium Base and Titanium Base C for GM Exact are intended to be manufactured at a validated milling center. The limits for customization are stated in the GM Exact Titanium Base and Titanium Base C for GM Exact product IFU. The superstructure produced through CAD/CAM System will compose the second part of the two-piece abutment; the assembly becomes a finished medical device after cementation on the GM Exact Titanium
5
Base or Titanium Base C for GM Exact. The GM Exact Titanium Base is indicated for screw-retained single-unit, or cement-retained single or multi-unit prosthesis attachment onto implants. The Titanium Base C for GM Exact is indicated for cement-retained single-unit prosthesis attachment onto implants.
The subject device abutments components mate exclusively with the GM implants cleared in K163194.
PERFORMANCE DATA
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization validation according to ISO 11137-1, ISO 11137-2. ISO 11135, ISO 10993-7, ISO 17665-1, ISO 17665-2, and ISO 11135 10993-7 (referenced from K163194); bacterial endotoxin according to AAMI/ANSI ST72 (referenced from K163194); sterile barrier shelf life testing (accelerated aging according to ASTM F1980; seal integrity according to ASTM E499/E499M and ASTM F1929; seal strength according to ASTM F88/F88M; and sterility of the package contents according to ISO 11737, all referenced from K163194); biocompatibility (referenced from K163194); engineering analysis; dimensional analysis; and static and dynamic compression-bending to ISO 14801. Clinical data were not submitted in this premarket notification.
EQUIVALENCE TO MARKETED DEVICES
IJGC 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 and reference devices:
K163194. Neodent Implant System - GM Line, JJGC Indústria e Comércio de Materiais Dentários S.A .; K 123022, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A .; K160964, Neodent Implant System - Titanium Bases for CEREC, JJGC Indústria e Comércio de Materiais Dentários S.A.; and
K150367, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A.
A comparison of the Indications for Use statements for the subject device and the predicate and reference devices is provided in the following table.
6
Table of Substantial Equivalence – Indications for Use Statements
| Subject Device | Primary Predicate Device | Reference Devices | |||
|---|---|---|---|---|---|
| Comparison | K180536 | K163194 | K123022 | K160964 | K150367 |
| Neodent Implant System - GM Line | Neodent Implant System - GM Line | Neodent Implant System | Neodent Implant System - Titanium | ||
| Bases for CEREC | Neodent Implant System | ||||
| JJGC Indústria e Comércio de | |||||
| Materiais Dentários S.A. | JJGC Indústria e Comércio de | ||||
| Materiais Dentários S.A. | JJGC Indústria e Comércio de | ||||
| Materiais Dentários S.A. | JJGC Indústria e Comércio de | ||||
| Materiais Dentários S.A. | JJGC Indústria e Comércio de | ||||
| Materiais Dentários S.A | |||||
| Indications for | |||||
| Use Statement | Indications for Use for GM Helix 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 Exact Titanium Block for | |||||
| Medentika Holder: | |||||
| GM Exact Titanium Block for Medentika Holder 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. The GM Exact Titanium Block for | |||||
| Medentika Holder abutments are indicated for screw- | |||||
| retained single restorations or cement-retained single | |||||
| or multi-unit restorations. All digitally designed | |||||
| abutments for use with the GM Exact Titanium Block | |||||
| for Medentika Holder are intended to be sent to | |||||
| Straumann for manufacture at a validated milling | |||||
| center. | |||||
| Indications for Use for GM Exact 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 | |||||
| validated milling center. | |||||
| Indications for Use for Titanium Base C for GM | |||||
| Exact abutments: | |||||
| The Titanium Base C for GM Exact abutments is a | |||||
| titanium component that is placed over Neodent | |||||
| implants to provide support for custom prosthetic | |||||
| restorations, such as copings or crowns. It is | |||||
| indicated for single-tooth screw-retained restorations. | |||||
| All digitally designed copings and/or crowns for use | |||||
| with the Titanium Base C for GM Exact abutments | |||||
| are to be designed using Sirona inLab software or | |||||
| Sirona CEREC Software and manufactured using a | |||||
| Sirona CEREC or inLab MC X or MC XL milling | |||||
| unit. | 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. | 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. | The Titanium Base for CEREC is a | ||||
| titanium component that is placed over | |||||
| Neodent Implants to provide support for | |||||
| custom prosthetic restorations, such as | |||||
| copings or crowns. It is indicated for | |||||
| single-tooth screw-retained restorations. | |||||
| All digitally designed copings and/or | |||||
| crowns for use with the Neodent Titanium | |||||
| Base for CEREC are to be designed using | |||||
| Sirona inLab software or Sirona CEREC | |||||
| Software and manufactured using a Sirona | |||||
| CEREC or inLab MC X or MC XL | |||||
| milling unit. | 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. |
7
The Indications for Use Statement for the subject device (implants and conventional abutments section) is identical to the corresponding section of the Indications for Use Statement of the primary predicate device K163194. The Indications for Use Statement for the subject device (implants section) is identical to the corresponding section of the Indications for Use Statement of the reference device K123022. The Indications for Use Statement for the subject device (GM Exact Titanium Base abutments section) is identical to the corresponding section of the Indications for Use Statement of K163164 (GM Titanium Base abutments section), except for the names of the devices. The conventional abutments in this submission are the GM Customizable Healing Abutment. The subject device GM Exact Titanium Base abutments and Titanium Base C for GM Exact abutments are not considered conventional abutments. The slight differences in wording among the Indications for Use Statements for the subject device, K163194, and K123022 do not affect the intended use with dental implants for rehabilitation of the edentulous maxilla or mandible.
The Indications for Use Statement for the subject device (GM Exact Titanium Block for Medentika Holder section) is similar to the PreFace section of the Indications for Use Statement of the reference device K150367. The slight differences are the names of the devices (both are to be used with Medentika holder) and, for the subject device statement, the requirement to manufacture at a Straumann milling center. For K160367 the requirement to manufacture at a Straumann milling center was included in the labeling. The slight differences in wording between the Indications for Use Statements for the subject device and the reference device K150367 do not affect the intended use with dental implants for rehabilitation of the edentulous maxilla or mandible.
The Indications for Use Statement for the subject device (Titanium Base C for GM Exact abutments section) is similar to the Indications for Use Statement of the reference device K160964. The slight difference is the names of the devices. The slight differences in wording between the Indications for Use Statements for the subject device and the reference device K160964 do not affect the intended use with dental implants for rehabilitation of the edentulous maxilla or mandible.
A comparison of the technological characteristics of the subject device and the predicate and reference devices is provided in the following table.
8
510(k) Summary Page 6 of 9
Table of Substantial Equivalence – Technological Characteristics
| Subject Device | Primary Predicate Device | Technological Characteristics | Reference Devices | ||
|---|---|---|---|---|---|
| Comparison | K180536 | K163194 | K123022 | K160964 | K150367 |
| Neodent Implant System - GM Line | Neodent Implant System - GM Line | Neodent Implant System | Neodent Implant System - Titanium | ||
| Bases for CEREC | Neodent Implant System | ||||
| JJGC Indústria e Comércio de | |||||
| Materiais Dentários S.A. | JJGC Indústria e Comércio de | ||||
| Materiais Dentários S.A. | JJGC Indústria e Comércio de | ||||
| Materiais Dentários S.A. | JJGC Indústria e Comércio de | ||||
| Materiais Dentários S.A. | JJGC Indústria e Comércio de | ||||
| Materiais Dentários S.A | |||||
| Reason for | |||||
| Predicate | Not applicable | Implant-abutment GM interface; | |||
| Implant design; Healing Abutment | |||||
| design; Titanium Base designs | Implant design, 6 mm diameter | Titanium Base C design | Titanium Block (milling) design | ||
| Implants | |||||
| Implant Design | Threaded root-form implants, 1 thread design; | ||||
| Internal GM Morse taper connection (16°), | |||||
| with internal hex indexing feature ("Exact") | Threaded root-form implants, 3 | ||||
| thread designs; | |||||
| Internal GM Morse taper | |||||
| connection(16°), with internal hex | |||||
| indexing feature ("Exact") | Threaded root-form implants, 3 | ||||
| thread designs; | |||||
| Internal CM Morse taper | |||||
| connection(11.5°) | |||||
| Implant Diameter | GM Helix: 6.0 mm | GM Helix: 3.5, 3.75, 4.0, 4.3, 5.0 | |||
| mm | Titamax WS implant: 4.0, 5.0, 6.0 | ||||
| mm | |||||
| Implant Length | GM Helix: 8, 10, 11.5, 13 mm | GM Helix: 8, 10, 11.5, 13, 16, 18 | |||
| mm | Titamax WS implant: 5, 6 mm | ||||
| Material | Unalloyed titanium ASTM F67 | Unalloyed titanium ASTM F67 | Titamax WS implant: Unalloyed | ||
| titanium ASTM F67 | |||||
| Endosseous | |||||
| surface | NeoPoros (grit-blasted, acid-etched | ||||
| Acqua (NeoPoros + hydrophilic treatment) | NeoPoros (grit-blasted, acid-etched | ||||
| Acqua (NeoPoros + hydrophilic | |||||
| treatment) | NeoPoros (grit-blasted, acid-etched | ||||
| Abutments | |||||
| Healing | |||||
| Abutment | GM Customizable Healing Abutment | GM Pro PEEK Abutment | |||
| Body (prosthetic) | |||||
| diameter | 5.5 mm and 7.0 mm | 4.5 mm and 6.0 mm | |||
| Gingival height | 5.5 mm Ø: 1.5, 2.5, 3.5, 4.5, 5.5 mm | ||||
| 7.0 mm Ø: 2.5, 3.5, 4.5, 5.5, 6.5 mm | 4.5 mm Ø: 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 | ||||
| mm | |||||
| 6.0 mm Ø: 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 | |||||
| mm | |||||
| Material | Titanium alloy ASTM F136 (interface to | ||||
| implant) | |||||
| PEEK (customizable portion) | Titanium alloy ASTM F136 | ||||
| (interface to implant) | |||||
| PEEK (customizable portion) | |||||
| Implant interface | Interfaces exclusively to Neodent GM | ||||
| implants | Interfaces exclusively to Neodent | ||||
| GM implants | |||||
| Titanium Block | |||||
| (milling) | GM Exact Titanium Block for Medentika | ||||
| Holder | GM Exact Click Universal Abutment | ||||
| 30° | PreFace | ||||
| Body (milling) | |||||
| diameter | 11.5 mm and 15.8 mm | n/a | 11.5 mm and 15.8 mm | ||
| Abutment angle | 15.8 mm Ø only: up to 30° | 0°, 17°, 30° | 15.8 mm Ø only: up to 30° | ||
| Prosthesis | |||||
| attachment | Screw-retained single-unit, or | ||||
| Cement-retained single or multi-unit | Cement-retained single-unit | Screw-retained single-unit, or | |||
| Cement-retained single or multi-unit | |||||
| Material | Titanium alloy ASTM F136 | Titanium alloy ASTM F136 | Titanium alloy ASTM F136 | ||
| Comparison | Subject Device | Primary Predicate Device | Reference Devices | ||
| K180536 | K163194 | K123022 | K160964 | K150367 | |
| Implant interface | Interfaces exclusively to GM implants | Interfaces exclusively to GM | |||
| implants | Interfaces exclusively to Neodent | ||||
| CM Morse taper implants | |||||
| Titanium Base | GM Exact Titanium Base | GM Exact Titanium Base | Titanium Base | ||
| Body (prosthetic) | |||||
| diameter | 5.5 mm | 3.5 mm and 4.5 mm | 3.5 mm and 4.5 mm | ||
| Abutment angle | Up to 30° | Up to 30° | Up to 30° | ||
| Gingival height | 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 mm | 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 mm | 0.8, 1.5, 2.5, 3.5, 4.5 mm | ||
| Prosthetic post | |||||
| height | 4 mm and 6 mm | 4 mm and 6 mm | 4 mm | ||
| Prosthesis | |||||
| attachment | Screw-retained single-unit, or | ||||
| Cement-retained single or multi-unit | Cement-retained single-unit | Screw-retained single-unit, or | |||
| Cement-retained single or multi-unit | |||||
| Material | Titanium alloy ASTM F136 | Titanium alloy ASTM F136 | Titanium alloy ASTM F136 | ||
| Implant interface | Interfaces exclusively to Neodent GM | ||||
| implants | Interfaces exclusively to Neodent | ||||
| GM implants | Interfaces exclusively to Neodent | ||||
| CM Morse taper implants (11.5° | |||||
| Morse taper) | |||||
| Titanium Base | Titanium Base C for GM Exact | GM Exact Titanium Base | Titanium Base for CEREC | ||
| Body (prosthetic) | |||||
| diameter | 4.65 mm | 3.5 mm and 4.5 mm | 4.65 mm | ||
| Abutment angle | Up to 20° | Up to 30° | Up to 30° | ||
| Gingival height | 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 mm | 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 mm | 0.8, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5 mm | ||
| Prosthetic post | |||||
| height | 4.7 mm | 4 mm and 6 mm | 4.7 mm | ||
| Prosthesis | |||||
| attachment | Cement-retained single-unit | Cement-retained single-unit | Screw-retained single-unit | ||
| Material | Titanium alloy ASTM F136 | Titanium alloy ASTM F136 | Titanium alloy ASTM F136 | ||
| Implant interface | Interfaces exclusively to Neodent GM | ||||
| implants | Interfaces exclusively to Neodent | ||||
| GM implants | Interfaces exclusively to Neodent | ||||
| CM Morse taper implants (11.5° | |||||
| Morse taper) |
9
510(k) Summary
Page 7 of 9
10
The primary predicate device K163194 is for substantial equivalence of the subject device implants and the GM Morse taper abutment-implant interface design. All subject device abutments have the identical abutment-implant interface design as, and are to mate exclusively with, the Neodent GM implants cleared in K163194.
The subject device GM Helix implants are provided in the same design as the GM Helix implants cleared in K163194, with the exception of the additional 6 mm diameter. The reference device K123022 is for the 6 mm diameter size.
The subject device GM Customizable Healing Abutments are provided in the same abutment-implant interface design, gingival heights, and material as the GM Pro PEEK Abutments cleared in K163194. The subject device healing abutments and the GM Pro PEEK Abutments cleared in K163194 are both for temporary use and are not to be placed in occlusion: therefore, the larger prosthetic diameter of the subject device (7 mm) does not affect the substantial equivalence comparison to K163194.
The subject device GM Exact Titanium Block for Medentika Holder milling abutment is provided in the same design as the PreFace milling abutment cleared in K150367, except for the abutment-implant interface. The subject device mates exclusively with GM Morse taper implants; the PreFace device in K150367 mates exclusively with CM Morse taper implants. The limits of customization for the subject device GM Exact Titanium Block for Medentika Holder are identical to the GM Exact Click Universal Abutment 30°, which was cleared in K163194 and mates exclusively with GM Morse taper implants.
The subject device GM Exact Titanium Base abutments are provided in the same abutment-implant interface design, gingival heights, and material as the GM Exact Titanium Base abutments cleared in K 163194. The subject device GM Exact Titanium Base abutments add a 5.5 mm prosthetic diameter. Therefore, the larger prosthetic diameter of the subject device does not create any additional risks or affect the substantial equivalence comparison to K163194. Mechanical testing according to ISO 14801 was provided to confirm the strength of the GM Exact Titanium Base abutment (5.5 mm diameter, 0.8 mm gingival height).
The subject device Titanium Base C for GM Exact abutments are provided in the same design as the Titanium Base for CEREC devices cleared in K160964, except for the abutment-implant interface. The subject device mates exclusively with GM Morse taper implants; the Titanium Base for CEREC device in K160964 mates exclusively with CM Morse taper implants. Engineering analysis was performed to demonstrate that the subject device Titanium Base C for GM Exact abutments (limited to 20° of angulation) are equivalent to the GM Exact Titanium Base in K163194 (limited to 30° of angulation). The subject device Titanium Base C for GM Exact abutments and the GM Exact Titanium Base cleared in K163194 mate exclusively with GM Morse taper implants.
Substantial equivalence of the subject device components in terms of biocompatibility is supported by the fact that the unalloyed titanium alloy, and PEEK materials used in the subject devices are identical in formulation, processing, component interactions, and storage conditions to the predicate devices in K163194.
In support of substantial equivalence in terms of mechanical performance, dynamic compression-bending testing was performed according to ISO 14801 on worst-case subject device constructs. The results from the testing demonstrated fatigue performance of the subject device GM Exact Titanium Base to be substantially equivalent to that of the predicate device K163194.
11
The data included in this submission demonstrate substantial equivalence to the predicate and reference devices listed above. Any differences in the technological characteristics between the subject and the predicate and reference devices do not raise different questions of safety or effectiveness.
CONCLUSION
The subject device and the predicate and reference devices have 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 and reference devices listed above.