(127 days)
No
The document describes a dental implant system and its components, focusing on materials, intended use, manufacturing processes (including digital design and milling), and performance testing related to shelf life and biocompatibility. There is no mention of AI or ML technologies being used in the device itself or in its operation.
Yes
The device is intended to be surgically placed in the bone to provide support for prosthetic devices to restore chewing function, which addresses a medical condition or ailment.
No
The Neodent Implant System is indicated for surgically placing in the bone to support prosthetic devices like artificial teeth, rather than for diagnosing any condition.
No
The device description clearly states the device is a physical implant made of titanium, provided sterile, and intended for surgical placement. It also describes physical components like abutments and blocks. While there are mentions of digitally designed components and milling, the core device is a physical implant system, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is surgically placed in the bone to support prosthetic devices for restoring chewing function. This is a surgical implant, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical characteristics of the implant (material, surface treatment, sterilization, etc.) and its compatibility with other components of the dental implant system. This aligns with a surgical device.
- Performance Studies: The performance studies described are related to the physical integrity, surface properties (hydrophilicity), packaging, and biological safety of the implant after shelf life. These are typical tests for a medical device intended for implantation, not for an IVD.
- Key Metrics: The key metrics measured (dynamic contact angle, packaging integrity, cytotoxicity) are relevant to the performance and safety of a surgical implant, not to the analytical or clinical performance of an IVD.
In summary, the device is a dental implant system, which is a type of surgical medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- Neodent Implant System (originally cleared per K133592)
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.
- Neodent Implant System (originally cleared per K150182)
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
- Neodent Implant System (originally cleared per K150199)
CM Alvim Acqua Implant
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.
Facility Acqua Implant
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
The Facility implant is indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures.
CM Anatomic Abutment, Exact Anatomic, Lateral Anatomic, and Lateral Anatomic Abutments
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
- Neodent Implant System - GM Line (originally cleared per K163194)
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 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.
- Neodent Implant System - GM Line (originally cleared per K180536)
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 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 cemented-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 cemented-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
Device Description
The present submission is for an increase in the shelf life of the Neodent Implant System having the Acqua surface treatment; the shelf life is being extended from 2-years.
The subject devices are:
- Intended for single use;
- Provided sterile via gamma irradiation;
- Manufactured of commercially pure titanium grade 4;
- Root-form, threaded implants with Acqua surface treatment;
- Compatible with several implant-to-abutment interfaces of the Neodent Implant System as presented in the Comparison Tables below.
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)
The tests performed to support the request for shelf life extension were the following:
- Product integrity after shelf life;
- Maintenance of hydrophilicity characteristics of the Acqua surface treatment after shelf life:
- Package integrity testing after shelf life;
- Biological safety of the product after shelf life.
The hydrophilicity presented a dynamic contact angle of 0° when the acceptance criteria is a dynamic contact of
§ 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). 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.
April 28, 2020
JJGC Industria e Comercio de Materiais Dentarios S.A. % Jennifer Jackson Director of Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K193592
Trade/Device Name: Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: April 10, 2020 Received: April 13, 2020
Dear Jennifer Jackson:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) K193592
Device Name
Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants
Indications for Use (Describe)
- Neodent Implant System (originally cleared per K133592)
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
3
510(k) Number (if known) K193592
Device Name
Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants
Indications for Use (Describe)
- Neodent Implant System (originally cleared per K150182)
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
4
510(k) Number (if known) K193592
Device Name
Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants
Indications for Use (Describe)
- Neodent Implant System (originally cleared per K150199)
CM Alvim Acqua Implant
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.
Facility Acqua Implant
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
The Facility implant is indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures.
CM Anatomic Abutment, Exact Anatomic, Lateral Anatomic, and Lateral Anatomic Abutments
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------- | ----------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
5
510(k) Number (if known) K193592
Device Name
Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants
Indications for Use (Describe)
- Neodent Implant System - GM Line (originally cleared per K163194)
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 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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
6
510(k) Number (if known) K193592
Device Name
Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants
Indications for Use (Describe)
- Neodent Implant System - GM Line (originally cleared per K180536)
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 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 cemented-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 cemented-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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
7
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
8
K193592 - Neodent Implant System – Change in the Shelf Life of Neodent Acqua Implants
| 510(k) Summary | |
|---|---|
| ADMINISTRATIVE INFORMATION | |
| Sponsor | JJGC Indústria e Comércio de Materiais Dentários SA |
| (dba Neodent) | |
| Av. Juscelino Kubitschek de Oliveira, 3291 | |
| Curitiba, Parana, Brazil 81270-200 | |
| Registration No.: 3008261720 | |
| Owner/Operator No.: 10031702 | |
| Contact Person | Jennifer M. Jackson, MS |
| Director of Regulatory Affairs, | |
| Straumann USA | |
| E-mail: jennifer.jackson@straumann.com | |
| Telephone (978) 747-2509 | |
| Date Prepared | 28/Apr/2020 |
| Preparer / Alternate Contact | Mariana Soares Hartmann |
| Regulatory Affairs Analyst | |
| E-mail: mariana.hartmann@neodent.com | |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/ Proprietary Name | |
| Acqua Implants | Neodent Implant System – Change in the Shelf Life for Neodent |
| Common Name | Endosseous dental implant |
| Classification Name | Implant, Endosseous, Root-Form |
| Classification Regulations | 21 CFR 872.3640, Class II |
| Product Code | DZE |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
| PREDICATE DEVICE INFORMATION | |
| Predicate Devices | K133592 – Neodent Implant System, JJGC Indústria e Comércio de |
| Materiais Dentários S.A. |
9
K150182 - Neodent Implant System - CM Drive Implants, JJGC Indústria e Comércio de Materiais Dentários S.A;
K150199 – Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A;
K163194, Neodent Implant System - GM Line, JJGC Indústria e Comércio de Materiais Dentários S.A;
K180536, Neodent Implant System – GM Line, JJGC Indústria e Comércio de Materiais Dentários S.A.
K182620, MRI Compatibility For Existing Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A.
INDICATIONS FOR USE
Indications for Use K133592
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.
Indications for Use K150182
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 K150199
CM Alvim Acqua Implant
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.
Facility Acqua Implant
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
The Facility implant is indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures.
CM Anatomic Abutment, Exact Anatomic, Lateral Anatomic, and Lateral Anatomic Abutments
10
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 K163194
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.
Indications for Use K180536
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 screwretained single restorations or cemented-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 cemented-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.
11
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 DESCRIPTIONS
The present submission is for an increase in the shelf life of the Neodent Implant System having the Acqua surface treatment; the shelf life is being extended from 2-years.
The subject devices are:
- Intended for single use;
- Provided sterile via gamma irradiation;
- Manufactured of commercially pure titanium grade 4;
- Root-form, threaded implants with Acqua surface treatment;
- Compatible with several implant-to-abutment interfaces of the Neodent Implant System as presented in the Comparison Tables below.
12
TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | |
|---|---|---|
| Neodent Implant System - Change in the Shelf Life for | ||
| Neodent Acqua Implants | ||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | K133592 | |
| Neodent Implant System | ||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | ||
| Indications for | ||
| Use | The Neodent Implant System is intended to be surgically | |
| placed in the bone of the upper or lower jaw to provide | ||
| support for prosthetic devices such as artificial teeth, to | ||
| restore chewing function. It may be used with single- | ||
| stage or two-stage procedures, for single or multiple unit | ||
| restorations, and may be loaded immediately when good | ||
| primary stability is achieved and with appropriate | ||
| occlusal loading. Multiple tooth applications may be | ||
| rigidly splinted. | The Neodent Implant System is intended to be surgically | |
| placed in the bone of the upper or lower jaw to provide | ||
| support for prosthetic devices such as artificial teeth, to | ||
| restore chewing function. It may be used with single- | ||
| stage or two-stage procedures, for single or multiple unit | ||
| restorations, and may be loaded immediately when good | ||
| primary stability is achieved and with appropriate | ||
| occlusal loading. Multiple tooth applications may be | ||
| rigidly splinted. | ||
| Design | An external hex threaded root-form implant to be used | |
| with mating abutments having an integral anti-rotation | ||
| feature. | An external hex threaded root-form implant to be used | |
| with mating abutments having an integral anti-rotation | ||
| feature. | ||
| Reusable | No | No |
| Dimensions | Titamax Ti EX Acqua and Titamax Smart EX Acqua: | |
| Implant Ø: 3.75, 4.0 mm | ||
| Length: 9, 11, 13, 15, 17 mm | ||
| Platform Ø: 4.1 mm |
Drive Ti Acqua and Drive Smart Acqua:
Implant Ø: 3.5, 4.3, 5.0 mm
Length: 8, 10, 11.5, 13, 16
mm
Platform Ø: 3.3, 4.3, 5.0 mm
Titamax CM EX Acqua:
Implant Ø: 3.5, 3.75, 4.0mm
Length: 9, 11, 13, 15, 17, 19 mm
Platform Ø: 3.5, 3.75, 4.0mm
Drive CM Acqua:
Implant Ø: 3.5, 4.3, 5.0 mm
Length: 8, 10, 11.5, 13, 16 mm
Platform Ø: 3.5, 3.9 mm | Titamax Ti EX Acqua and Titamax Smart EX Acqua:
Implant Ø: 3.75, 4.0 mm
Length: 9, 11, 13, 15, 17 mm
Platform Ø: 4.1 mm
Drive Ti Acqua and Drive Smart Acqua:
Implant Ø: 3.5, 4.3, 5.0 mm
Length: 8, 10, 11.5, 13, 16
mm
Platform Ø: 3.3, 4.3, 5.0 mm
Titamax CM EX Acqua:
Implant Ø: 3.5, 3.75, 4.0mm
Length: 9, 11, 13, 15, 17, 19 mm
Platform Ø: 3.5, 3.75, 4.0mm
Drive CM Acqua:
Implant Ø: 3.5, 4.3, 5.0 mm
Length: 8, 10, 11.5, 13, 16 mm
Platform Ø: 3.5, 3.9 mm |
| Material | Commercially pure titanium, grade 4 | Commercially pure titanium, grade 4 |
| Sterilization
Method | Gamma irradiation, 25 kGy min. | Gamma irradiation, 25 kGy min. |
| Shelf Life | 4 years | 2 years |
| Table 1. Comparative table between subject implants and previously cleared implants per K133592 | |||
|---|---|---|---|
13
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | |
|---|---|---|
| Neodent Implant System - Change in the Shelf Life for | ||
| Neodent Acqua Implants | ||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | K150182 | |
| Neodent Implant System - CM Drive Implants | ||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | ||
| 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. | 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. | ||
| Design | An external hex threaded root-form implant to be used | |
| with mating abutments having an integral anti-rotation | ||
| feature. | An external hex threaded root-form implant to be used | |
| with mating abutments having an integral anti-rotation | ||
| feature. | ||
| Reusable | No | No |
| Dimensions | Implant Ø: 3.5, 4.3 and 5.0 mm | |
| Length: 18 mm | ||
| Platform Ø: 3.5, 3.9 and 5.0 mm | Implant Ø: 3.5, 4.3 and 5.0 mm | |
| Length: 18 mm | ||
| Platform Ø: 3.5, 3.9 and 5.0 mm | ||
| Material | Commercially pure titanium, grade 4 | Commercially pure titanium, grade 4 |
| Sterilization | ||
| Method | Gamma irradiation, 25 kGy min. | Gamma irradiation, 25 kGy min. |
| Shelf Life | 4 years | 2 years |
| Table 2. Comparative table between subject implants and previously cleared implants per K150182 | |||
|---|---|---|---|
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | ||
| Neodent Implant System - Change in the Shelf Life for | |||
| Neodent Acqua Implants | |||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | K150199 | ||
| Neodent Implant System | |||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | |||
| Indications for | |||
| Use | CM Alvim Acqua Implant | CM Alvim Acqua Implant | |
| The Neodent Implant System is intended to be surgically | |||
| placed in the bone of the upper or lower jaw to provide | |||
| support for prosthetic devices such as artificial teeth, to | |||
| restore chewing function. It may be used with single- | |||
| stage or two-stage procedures, for single or multiple unit | |||
| restorations, and may be loaded immediately when good | |||
| primary stability is achieved and with appropriate | |||
| occlusal loading. Multiple tooth applications may be | |||
| rigidly splinted. | The Neodent Implant System is intended to be surgically | ||
| placed in the bone of the upper or lower jaw to provide | |||
| support for prosthetic devices such as artificial teeth, to | |||
| restore chewing function. It may be used with single- | |||
| stage or two-stage procedures, for single or multiple unit | |||
| restorations, and may be loaded immediately when good | |||
| primary stability is achieved and with appropriate | |||
| occlusal loading. Multiple tooth applications may be | |||
| rigidly splinted. | |||
| Facility Acqua Implant | Facility Acqua Implant | ||
| The Neodent Implant System is intended to be surgically | |||
| placed in the bone of the upper or lower jaw to provide | |||
| support for prosthetic devices such as artificial teeth, to | |||
| restore chewing function. It may be used with single- | |||
| stage or two-stage procedures, for single or multiple unit | |||
| restorations, and may be loaded immediately when good | |||
| primary stability is achieved and with appropriate | |||
| occlusal loading. | The Neodent Implant System is intended to be surgically | ||
| placed in the bone of the upper or lower jaw to provide | |||
| support for prosthetic devices such as artificial teeth, to | |||
| restore chewing function. It may be used with single- | |||
| stage or two-stage procedures, for single or multiple unit | |||
| restorations, and may be loaded immediately when good | |||
| primary stability is achieved and with appropriate | |||
| occlusal loading. | |||
| The Facility implant is indicated for replacement of | |||
| maxillary lateral incisors, mandibular incisors or retention | |||
| of overdentures. | The Facility implant is indicated for replacement of | ||
| maxillary lateral incisors, mandibular incisors or retention | |||
| of overdentures. | |||
| CM Anatomic Abutment, Exact Anatomic, Lateral | |||
| Anatomic, and Lateral Anatomic Abutments | CM Anatomic Abutment, Exact Anatomic, Lateral | ||
| Anatomic, and Lateral Anatomic Abutments | |||
| The Neodent Implant System is intended to be surgically | |||
| placed in the bone of the upper or lower jaw to provide | |||
| support for prosthetic devices such as artificial teeth, to | |||
| restore chewing function. It may be used with single- | |||
| stage or two-stage procedures, for single or multiple unit | |||
| restorations, and may be loaded immediately when good | |||
| primary stability is achieved and with appropriate | |||
| occlusal loading. | 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. | |||
| Design | An indexed Morse taper threaded root-form implant to | ||
| be used with mating abutments. | An indexed Morse taper threaded root-form implant to | ||
| be used with mating abutments. | |||
| Reusable | No | No | |
| Dimensions | Platform Ø: 3.5, 4.3, 5.0 mm | Platform Ø: 3.5, 4.3, 5.0 mm | |
| Implant Ø: 3.5, 4.3, 5.0 mm | Implant Ø: 3.5, 4.3, 5.0 mm | ||
| Length: 8, 10, 11.5, 13, 16 mm | Length: 8, 10, 11.5, 13, 16 mm | ||
| Material | Commercially pure titanium, grade 4 | Commercially pure titanium, grade 4 | |
| Sterilization | |||
| Method | Gamma irradiation, 25 kGy min. | Gamma irradiation, 25 kGy min. | |
| Shelf Life | 4 years | 2 years | |
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | ||
| Neodent Implant System - Change in the Shelf Life for | |||
| Neodent Acqua Implants | |||
| 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 | Indications for Use for GM implants and conventional | ||
| abutments: | 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. | 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: | 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. | 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. | 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. | 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. | |||
| Design | The dental implants are threaded, self-tapping, root | ||
| form and present a Morse taper implant-to-abutment | |||
| interface with an internal hexagonal index exclusive to | |||
| the GM line. | The dental implants are threaded, self-tapping, root | ||
| form and present a Morse taper implant-to-abutment | |||
| interface with an internal hexagonal index exclusive to | |||
| the GM line. | |||
| Reusable | No | No | |
| Dimensions | Implant Ø: 3.5 to 5.0 mm | ||
| Length: 8 to 18 mm | Implant Ø: 3.5 to 5.0 mm | ||
| Length: 8 to 18 mm | |||
| Material | Commercially pure titanium, grade 4 | Commercially pure titanium, grade 4 | |
| Sterilization | |||
| Method | Gamma irradiation, 25 kGy min. | Gamma irradiation, 25 kGy min. | |
| Shelf Life | 4 years | 2 years |
14
Table 3. Comparative table between subject implants and previously cleared implants per K150199
15
| Table 4. Comparative table between subject implants and previously cleared implants per K163194 | |||
|---|---|---|---|
| ------------------------------------------------------------------------------------------------- | -- | -- | -- |
16
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | |
|---|---|---|
| Neodent Implant System - Change in the Shelf Life for | ||
| Neodent Acqua Implants | ||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | K180536 | |
| Neodent Implant System - GM Line | ||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | ||
| Indications for | ||
| Use | Indications for Use for GM Helix Implants and conventional | |
| abutments: | 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. | 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: | 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 cemented-retained single or multi-unit | ||
| restorations. | 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 cemented-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. | 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: | 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 cemented-retained single or multi-unit | ||
| restorations, or screw-retained single restorations. | 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 cemented-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. | 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: | 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. | 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. | ||
| Design | Threaded root-form implants, 1 thread design; Internal | |
| GM Morse taper connection (16°), with internal hex | ||
| indexing feature ("Exact") | Threaded root-form implants, 1 thread design; Internal | |
| GM Morse taper connection (16°), with internal hex | ||
| indexing feature ("Exact") | ||
| Reusable | No | No |
| Dimensions | Implant Ø: 6.0 mm | Implant Ø: 6.0 mm |
| Length: 8, 10, 11.5, 13, 16, 18 mm | Length: 8, 10, 11.5, 13, 16, 18 mm | |
| Material | Commercially pure titanium, grade 4 | Commercially pure titanium, grade 4 |
| Table 5. Comparative table between subject implants and previously cleared implants per K180536 | |||
|---|---|---|---|
| ------------------------------------------------------------------------------------------------- | -- | -- | -- |
17
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | |
|---|---|---|
| Neodent Implant System - Change in the Shelf Life for | ||
| Neodent Acqua Implants | ||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | K180536 | |
| Neodent Implant System - GM Line | ||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | ||
| Sterilization | ||
| Method | Gamma irradiation, 25 kGy min. | Gamma irradiation, 25 kGy min. |
| Shelf Life | 4 years | 2 years |
SUBSTANTIAL EQUIVALENCE DISCUSSION
The subject devices and the predicate devices K133592, K150199, K163194 and K180536 have the same Indications for Use, same design, are manufactured using the same raw material and share the same sterilization method. The only change between them is the shelf life, which is the reason of this submission. The subject devices were originally cleared with a shelf life of 2 years. After a real-time aging study the company has determined that the shelf life of the implants can be extended to 4 years.
PERFORMANCE DATA
The tests performed to support the request for shelf life extension were the following:
- . Product integrity after shelf life;
- Maintenance of hydrophilicity characteristics of the Acqua surface treatment after shelf life:
- Package integrity testing after shelf life; ●
- Biological safety of the product after shelf life.
The hydrophilicity presented a dynamic contact angle of 0° when the acceptance criteria is a dynamic contact of