(215 days)
No
The summary describes physical dental implants and abutments and their intended use in surgical and restorative procedures. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No
Explanation: The device, Ditron's Dental Implants and Abutments, is indicated for providing support for prosthetic devices to restore chewing function. While it aids in restoring a physiological function, it is primarily a prosthetic support system and not a device that directly treats a disease or condition in a therapeutic manner.
No
The device description clearly states that Ditron's Dental Implants and Abutments are for surgical and restorative applications to provide support for prosthetic devices, not for diagnosing conditions.
No
The device description clearly details physical dental implants and abutments, which are hardware components. There is no mention of any software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the dental implants and abutments are for surgical and restorative applications within the bone of the jaw to support prosthetic devices and restore chewing function. This is a direct medical intervention on the patient's body.
- Device Description: The device description details physical implants and abutments made of titanium, designed to be surgically placed.
- 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 samples, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze biological samples. This device is surgically implanted inside the body.
N/A
Intended Use / Indications for Use
Ditron's Dental Implants and Abutments are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
· Two stage: MPI, ULT, API and CPI models
- · One stage: OPI and TPI models
The 3.3 and 3.0mm diameter models for One stage OPI and TPI, Two stage and API implants are intended only for the incisors and cuspids of the maxilla and mandible. They are also indicated for denture stabilization using multiple implants.
Two stage and One stage implants for temporary or long-term use: MPI, ULT, API, CPI, OPI and TPI are self-tapping Titanium threaded screws indicated for long term intra bony applications. They permit immediate splint stability and longterm fixation of new or existing crown, bridge and prosthesis and protection of graft sites.
MPI, ULT, API, CPI, OPI and TPI designs are indicated for immediate loading (except for MPI and API in 6.0mm length) when good primary stability is achieved and with appropriate occlusal loading.
MPI, ULT, API, CPI, OPI and TPI are indicated for immediate loading (except for MPI and API in 6.0mm length) in single tooth restorations when good primary stability is achieved with appropriate occlusal loading.
The 30-degree multi-unit abutments must be used within 45 degrees of parallelism for a splinted restoration. The 17-degree multi-unit abutments must be used within 32 degrees of parallelism for a splinted restoration.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
This submission covers changes related to Ditron's Dental implants and abutments. The inclusion of additional product variations aims to provide dental surgeons with a broader range of implant and abutment options for patient treatment.
The requested additions to Ditron's Dental Implants and Abutments within this 510(k) are hereby described:
. An additional implant type: TPI (Tissue Level (One Piece) Precision Implant) -The TPI design is based on Ditron's cleared MPI Implant model and the 3.0mm Straight Multi-Unit Abutment, creating a one-piece implant. The TPI's implant part is identical to the cleared MPI Implant model, and the 3.0mm MPI Straight Multi-unit part has minor dimensional modifications and color anodization for aesthetic purposes. The TPI compatible Cover and Prosthetic Screws are color anodized as well.
An additional Abutment type: TPI Healing Caps Abutment -● The TPI Healing Caps design is based on Ditron's cleared Cylindered Healing Caps. The TPI Healing Caps are color-anodized for aesthetic purposes. The TPI Healing Caps Abutments are available in several Gingival height dimensions of 3.5, 4.5 and 5.5mm.
- . Modification to Cleared Titanium Abutments – Addition of color anodization as an option for all of the Ditron Dental System Titanium Alloy Grade 23 (Ti 6Al-4V ELI) Abutments cleared under K140727 and K161497, to enhance the aesthetic outcome of the dental prosthetics.
- An additional Abutment type: TPI Titanium Coping Abutments The TPI ● Coping Abutment design is based on Ditron's cleared Temporary Abutment. The TPI Titanium Coping Abutments are directly connected to the endosseous dental implant and are intended to provide a basis for prosthetic restoration of single (Crown) or multiple teeth (Bridge). The TPI Titanium Coping Abutment is available in several lengths and restoration options: 11.0mm Bridge, 11.0 Crown, 4.5mm Bridge, 4.5mm Crown.
- An additional Abutment type: TPI Overdenture Liberator Abutment The TPI ● Overdenture Liberator Abutment design is based on Ditron's cleared Liberator Abutment. The Liberator Abutment is available in several length dimensions of 2.0, 3.0, 4.0 and 5.0mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw, incisors and cuspids of the maxilla and mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical and restorative applications
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 Performance Data:
- Biocompatibility: Biocompatibility evaluation and testing according to ISO 10993-1, ISO 10993-5, and ISO 10993-11, supported the substantial equivalence.
- Gamma Sterilization Validation: Gamma Sterilization was conducted according to ISO 11137-2 and AAMI TIR33 (replaced by ISO 13004:2022) using the VDmax method. All aspects of the Gamma sterilization process and tests remained unchanged as cleared under K140728. The sterilization results supported the SAL of at least 10-6.
- Pyrogen Testing (Bacterial Endotoxin): Pyrogen testing is performed using LAL (Limulus Amebocyte Lysate) method, in accordance with ANSI/AAMI ST72 standard, USP and USP . The TPI is part of routine quarterly LAL testing to comply with the testing limit of 20EU per device.
- Steam Sterilization Validation: Steam Sterilization was conducted according to ISO 17665 parts 1 and 2 and; ANSI AAMI ST79 using the overkill / half-cycle method. All aspects of the Steam sterilization validation process and tests remained unchanged as cleared under K140728. The steam sterilization validation results supported the SAL of at least 10-6.
- Surface testing: The implants' surface was evaluated by SEM scans and EDS analyses. All surface tests results met Ditron's specifications.
- Fatigue Testing: Being similar in dimensions to the primary predicate, the TPI provided in straight configuration only and in one-piece design, does not alter the worst-case scenario. The fatigue tests cleared under K140728 were conducted using worst case configuration and with accordance to ISO 14801 and FDA Guidance document for Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. These tests were not repeated as previously conducted tests cover the additional TPI Implant and abutments.
- Implant-Bone Contact Analysis (applicable for short implants with a length of 6.0mm): There has been no change in the surface contact, and therefore, these tests were not repeated.
- Implant Surface Area Analysis (applicable for short implants in length of 6.0mm): There has been no change in the surface area and therefore these tests were not repeated.
- Comparative pull-out test (applicable for short implants in length of 6.0mm): The previously cleared MPI model was tested using a worst-case configuration and therefore no additional testing was conducted.
- Shelf life: Shelf life and package integrity along 5 years was validated previously within Ditron K140728 cleared products. This test was not repeated since all aspects of packaging and sterile barrier materials, process and process parameters are identical for all Ditron implants (subject devices and cleared devices) as cleared under K140728. ISO 11607-1 standard was followed to establish 5 years shelf life and package integrity. All tests met their acceptance criteria.
- MRI Compatibility: MRI Compatibility was established based on evaluation against scientific literature (Woods et al., "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices") and product properties. It was concluded that the device is eligible to bear MR Conditional labeling.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Ditron Dental LTD Tali Hazan RA Consultant M.P Upper Galilee Ramot-Naftali, 1383000 ISRAEL
April 30, 2024
Re: K233231
Trade/Device Name: Dental Implants and Abutments Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: March 29, 2024 Received: April 1, 2024
Dear Tali Hazan:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
3
For comprehensive regulatory information about mediation-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,
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233231
Device Name Dental Implants and Abutments
Indications for Use (Describe)
Ditron's Dental Implants and Abutments are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
· Two stage: MPI, ULT, API and CPI models
- · One stage: OPI and TPI models
The 3.3 and 3.0mm diameter models for One stage OPI and TPI, Two stage and API implants are intended only for the incisors and cuspids of the maxilla and mandible. They are also indicated for denture stabilization using multiple implants.
Two stage and One stage implants for temporary or long-term use: MPI, ULT, API, CPI, OPI and TPI are self-tapping Titanium threaded screws indicated for long term intra bony applications. They permit immediate splint stability and longterm fixation of new or existing crown, bridge and prosthesis and protection of graft sites.
MPI, ULT, API, CPI, OPI and TPI designs are indicated for immediate loading (except for MPI and API in 6.0mm length) when good primary stability is achieved and with appropriate occlusal loading.
MPI, ULT, API, CPI, OPI and TPI are indicated for immediate loading (except for MPI and API in 6.0mm length) in single tooth restorations when good primary stability is achieved with appropriate occlusal loading.
The 30-degree multi-unit abutments must be used within 45 degrees of parallelism for a splinted restoration. The 17-degree multi-unit abutments must be used within 32 degrees of parallelism for a splinted restoration.
| 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) |
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4
Image /page/4/Picture/0 description: The image shows the logo for Ditron Dental. The logo consists of a green square with a white triangle cut out of the center on the left side. To the right of the square are the words "DITRON" on top of the word "DENTAL" in a sans-serif font.
510(k) Summary for
Ditron's Dental Implants and Abutments
Date Prepared: April 25, 2024
-
- Submitter
| Company name: | Ditron Precision Ltd. |
|---|---|
| Address: | 2 Haofe St Ashkelon, 78150 Israel |
| Phone: | +972-8-6711841 |
| E-mail: | ariel@ditronprecision.com |
Contact person:
| Name: | Ms. Tali Hazan – RA Consultant | ||
|---|---|---|---|
| Address: | Ramot Naftali, M.P Upper Galilee, 1383000, Israel | ||
| Phone: | +972-(0)50-5292-304 | ||
| E-mail: | tali.hazan@talmed.co.il |
-
- Device
Common or usual name: Dental Implants and Abutments Proprietary/Trade name: Dental Implants and Abutments Implants subtypes: TPI – Tissue Level (One Piece) Precision Implant Classification name: Endosseous Dental Implant (21 CFR 872.3640) Regulatory Class: II Product Code: Primary: DZE, Secondary: NHA
- Device
3. Predicate Device
The devices within this submission are substantially equivalent to the following predicate/reference devices:
- Primary Predicate Device: Ditron Precision Ltd's legally marketed Dental Implants and . Abutments, cleared under 510(k) number K140728.
- Reference Device: Ditron Precision Ltd's legally marketed Dental Implants and Abutments, . cleared under 510(k) number K161497.
- . Reference Device: TRI Dental Implants' legally marketed TRI-matrix® Tissue-Level implant, cleared under K203660.
5
Image /page/5/Picture/0 description: The image shows the logo for Ditron Dental. The logo consists of a green abstract shape on the left, followed by the words "DITRON" and "DENTAL" stacked on top of each other. The word "DITRON" is on the top line, and the word "DENTAL" is on the bottom line.
Device Description: 4.
This submission covers changes related to Ditron's Dental implants and abutments. The inclusion of additional product variations aims to provide dental surgeons with a broader range of implant and abutment options for patient treatment.
The requested additions to Ditron's Dental Implants and Abutments within this 510(k) are hereby described:
. An additional implant type: TPI (Tissue Level (One Piece) Precision Implant) -The TPI design is based on Ditron's cleared MPI Implant model and the 3.0mm Straight Multi-Unit Abutment, creating a one-piece implant. The TPI's implant part is identical to the cleared MPI Implant model, and the 3.0mm MPI Straight Multi-unit part has minor dimensional modifications and color anodization for aesthetic purposes. The TPI compatible Cover and Prosthetic Screws are color anodized as well.
An additional Abutment type: TPI Healing Caps Abutment -● The TPI Healing Caps design is based on Ditron's cleared Cylindered Healing Caps. The TPI Healing Caps are color-anodized for aesthetic purposes. The TPI Healing Caps Abutments are available in several Gingival height dimensions of 3.5, 4.5 and 5.5mm.
- . Modification to Cleared Titanium Abutments – Addition of color anodization as an option for all of the Ditron Dental System Titanium Alloy Grade 23 (Ti 6Al-4V ELI) Abutments cleared under K140727 and K161497, to enhance the aesthetic outcome of the dental prosthetics.
- An additional Abutment type: TPI Titanium Coping Abutments The TPI Titanium ● Coping Abutment design is based on Ditron's cleared Temporary Abutment. The TPI Titanium Coping Abutments are directly connected to the endosseous dental implant and are intended to provide a basis for prosthetic restoration of single (Crown) or multiple teeth (Bridge). The TPI Titanium Coping Abutment is available in several lengths and restoration options: 11.0mm Bridge, 11.0 Crown, 4.5mm Bridge, 4.5mm Crown.
- An additional Abutment type: TPI Overdenture Liberator Abutment The TPI ● Overdenture Liberator Abutment design is based on Ditron's cleared Liberator Abutment. The Liberator Abutment is available in several length dimensions of 2.0, 3.0, 4.0 and 5.0mm.
6
Image /page/6/Picture/0 description: The image shows the logo for Ditron Dental. The logo consists of a green letter D on the left and the words "DITRON DENTAL" in black on the right. The letter D is stylized with a white line running through it.
5. Indications for Use:
Ditron's Dental Implants and Abutments are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
- . Two stage: MPI, ULT, API and CPI models
- . One stage: OPI and TPI models
The 3.3 and 3.0mm diameter models for One stage OPI and TPI, Two stage and API implants are intended only for the incisors and cuspids of the maxilla and mandible. They are also indicated for denture stabilization using multiple implants.
Two stage and One stage implants for temporary or long-term use: MPI, ULT, API, CPI, OPI and TPI are self-tapping Titanium threaded screws indicated for long term intra bony applications. They permit immediate splint stability and long-term fixation of new or existing crown, bridge and prosthesis and protection of graft sites.
MPI, ULT, API, CPI, OPI and TPI designs are indicated for immediate loading (except for MPI and API in 6.0mm length) when good primary stability is achieved and with appropriate occlusal loading.
MPI, ULT, API, CPI, OPI and TPI are indicated for immediate loading (except for MPI and API in 6.0mm length) in single tooth restorations when good primary stability is achieved with appropriate occlusal loading.
The 30° multi-unit abutments must be used within 45 degrees of parallelism for a splinted restoration.
The 17° multi-unit abutments must be used within 32 degrees of parallelism for a splinted restoration.
Technological Characteristics and Substantial Equivalence: 6.
The subjected devices are substantially equivalent to Ditron's Dental Implants and Abutments that were cleared under K140728 and K161497, and with TRI Dental Implants' TRI-matrix® Tissue-Level implant cleared under K203660, as identified above under the 'predicate devices' section.
The indications for use are identical between the primary predicate and subject device indications for use statement, except for the addition of the TPI model. The additional TPI dental implants and abutments and Ditron's cleared predicate devices have the same indications for use, same shape, design and characteristics. The only characteristics that are not covered by the Ditron cleared predicates is the color anodization of the tissue level part of subject implant and abutments. This characteristic is equivalent to the TRI-matrix® Tissue-Level implant. All of the changes that differentiate the additional TPI dental implants and abutments from the predicate devices were addressed and evaluated.
7
Image /page/7/Picture/0 description: The image contains the logo for Ditron Dental. The logo consists of a green square with a white "V" shape inside, followed by the text "DITRON" in black, and "DENTAL" in black below it. The logo is simple and modern, with a focus on the company name.
Table 1: Substantial Equivalence Table - Intended use
| - Subject Device -
TPI Implant | - Primary Predicate Device -
Ditron's Dental Implants and
Abutments [MPI, OPI and Multi-Unit
Abutment] Cleared under K140728 | - Reference Device -
Ditron's Dental Implants and
Abutments [MPI L6.0mm and
Liberator] Cleared under K161497 | - Reference Device -
TRI Dental Implants'
TRI-matrix® Implant
Line [TRI-matrix®
Tissue-Level]
Cleared under
K203660 | Substantial
Equivalence
Discussion | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Ditron's Dental Implants and Abutments
are indicated for use in surgical and
restorative applications for placement in
the bone of the upper or lower jaw to
provide support for prosthetic devices,
such as artificial teeth, in order to restore
the patient's chewing function.
•Two stage: MPI, ULT, API and CPI
models
• One stage: OPI and TPI models
The 3.3 and 3.0mm diameter models for
One stage OPI and TPI, Two stage MPI,
Two stage and API implants are intended
only for the incisors and cuspids of the
maxilla and mandible. They are also
indicated for denture stabilization using
multiple implants.
Two stage and One stage implants for
temporary or long-term use: MPI, ULT,
API, CPI, OPI, and TPI are self-tapping
Titanium threaded screws indicated for
long term intra bony applications. They
permit immediate splint stability and long-
term fixation of new or existing crown, | Ditron's Dental Implants and
Abutments are indicated for use in
surgical and restorative applications
for placement in the bone of the
upper or lower jaw to provide support
for prosthetic devices, such as
artificial teeth, in order to restore the
patient's chewing function.
• Two stage: MPI, and CPI models
• One stage: OPI model
One stage and One piece OPI 3.3 and
3.0 mm diameter implants are
intended only for the incisors and
cuspids of the maxilla and mandible.
They are also indicated for denture
stabilization using multiple implants.
Two stage and One stage implants for
temporary or long-term use: MPI,
CPI, OPI are self-tapping Titanium
threaded screws indicated for long
term intra bony applications. They
permit immediate splint stability and
long-term fixation of new or existing
crown, bridge and prosthesis and
protection of graft sites. | Ditron's Dental Implants and Abutments are
indicated for use in surgical and restorative
applications for placement in the bone of the
upper or lower jaw to provide support for
prosthetic devices, such as artificial teeth, in
order to restore the patient's chewing
function.
• Two stage: MPI, ULT, API and CPI
models
• One stage: OPI model
The 3.3 and 3.0mm diameter models for One
stage OPI, Two stage MPI, Two stage and
API implants are intended only for the
incisors and cuspids of the maxilla and
mandible. They are also indicated for
denture stabilization using multiple
implants.
Two stage and One stage implants for
temporary or long-term use: MPI, ULT,
API, CPI, OPI are self-tapping Titanium
threaded screws indicated for long term intra
bony applications. They permit immediate
splint stability and long-term fixation of new
or existing crown, bridge and prosthesis and
protection of graft sites. | The TRI-matrix®
Implant Line is intended
for placement in the bone
of the maxillary or
mandibular arch for the
rehabilitation of
edentulous and partially
edentulous patients.
TRI-matrix® Implant
Line allows for one and
two stage surgical
procedures. When a one
stage surgical procedure
is applied, the implant
may be immediately
loaded when good
primary stability is
achieved and with
appropriate occlusal
loading. TRI-matrix®
Implant Line 6.5 mm
implants are intended for
delayed loading only.
The TRI-matrix® Crown | Same.
All predicate
devices
(primary and
references),
have the same
indications for
use. The MPI
length
dimensions
greater than
6.0mm, multi-
unit abutments,
and the One-
Piece design
concept were
leveraged from
510(k) K14072
and the 6.0mm
lengths of the
TPI together
with the
modified
Liberator, were | |
| | | | Abutment is intended for | leveraged from | |
| - Subject Device -
TPI Implant | - Primary Predicate Device -
Ditron's Dental Implants and
Abutments [MPI, OPI and Multi-Unit
Abutment] Cleared under K140728 | - Reference Device -
Ditron's Dental Implants and
Abutments [MPI L6.0mm and
Liberator] Cleared under K161497 | - Reference Device -
TRI Dental Implants'
TRI-matrix® Implant
Line [TRI-matrix®
Tissue-Level]
Cleared under
K203660 | Substantial
Equivalence
Discussion | |
| bridge and prosthesis and protection of | MPI, CPI, and OPI designs are | MPI, ULT, API, CPI and OPI designs are | use with an endosseous | 510(k) K161497 | |
| graft sites. | indicated for immediate loading when | indicated for immediate loading (except for | implant to function as a | for the addition | |
| MPI, ULT, API, CPI, OPI and TPI designs | good primary stability is achieved | MPI and API in 6.0mm length) when good | substructure that also | TPI model. | |
| are indicated for immediate loading | and with appropriate occlusal | primary stability is achieved and with | serves as the final | The TRI | |
| (except for MPI and API in 6.0mm length) | loading. MPI, CPI and OPI are | appropriate occlusal loading. | restoration, in a partially | reference device | |
| when good primary stability is achieved | indicated for immediate loading in | MPI, ULT, API, CPI and OPI are indicated | or completely edentulous | includes a | |
| and with appropriate occlusal loading. | single tooth restorations when good | for immediate loading (except for MPI and | patient. The abutment | crown that is not | |
| MPI, ULT, API, CPI, OPI and TPI are | primary stability is achieved with | API in 6.0mm length) in single tooth | screw is intended to | part of the | |
| indicated for immediate loading (except | appropriate occlusal loading. | restorations when good primary stability is | secure the TRI-matrix® | subject device | |
| for MPI and API in 6.0mm length) in | The 30-degree multi-unit abutments | achieved with appropriate occlusal loading. | Crown Abutment to the | and therefore | |
| single tooth restorations when good | must be used within 45 degrees of | The 30-degree multi-unit abutments must be | endosseous implant. | not applicable. | |
| primary stability is achieved with | parallelism for a splinted restoration. | used within 45 degrees of parallelism for a | | | |
| appropriate occlusal loading. | The 17-degree multi-unit abutments | splinted restoration. | | | |
| The 30° multi-unit abutments must be used | must be used within 32 degrees of | The 17-degree multi-unit abutments must be | | | |
| within 45 degrees of parallelism for a | parallelism for a splinted restoration. | used within 32 degrees of parallelism for a | | | |
| splinted restoration. | | splinted restoration. | | | |
| The 17° multi-unit abutments must be used | | | | | |
| within 32 degrees of parallelism for a | | | | | |
| splinted restoration. | | | | | |
| Feature | - Subject Device -
TPI Implant | Primary Predicate Device
Ditron's Dental Implants
and Abutments [MPI,
OPI and Multi-Unit
Abutment] Cleared
under K140728 | Reference Device -Ditron's
Dental Implants and
Abutments [MPI L6.0mm
and Liberator] Cleared under
K161497 | Reference Device -
TRI Dental Implants'
TRI-matrix® Implant
Line [TRI-matrix®
Tissue-Level]
Cleared under K203660 | Substantial Equivalence
Discussion |
| Material | Ti-6Al-4V-ELI | Ti-6Al-4V-ELI | Ti-6Al-4V-ELI | Ti-6Al-4V-ELI | Identical to all compared devices. |
| Patient
Population | Edentulous or partially
edentulous individuals | Edentulous or partially
edentulous individuals | Edentulous or partially
edentulous individuals | Edentulous and partially
edentulous individuals | Identical to all compared devices. |
| Placement
method | Placing the implant
immediately after
drilling | Placing the implant
immediately after drilling | Placing the implant
immediately after drilling | Placing the implant
immediately after drilling
(when a one-stage surgical
procedure is applied) | Identical to K140728 and K161497. |
| Maximum
Abutment
Angle | 0° | MPI: 0° - 30°
OPI: 0° | 30° for all implants except
for: Implants with L=6.0mm:
straight abutment only, and;
Implants with OD of less than
3.75mm: Up to 25°
Abutments only. | N/A since the reference
device is used only for the
tissue level surface
treatment (Color
anodization) comparison. | Similar.
All angles are within the cleared
range. |
| Construction | Machined | Machined | Machined | Machined | Identical to all compared devices. |
| Surface
Treatment | • Sand alumina large
grit blasting and Acid
etching
• Color using
anodization (Blue,
Yellow-gold, Pink-
Purple and Green) of | • Implants (OPI & MPI):
Sand alumina large grit
blasting and Acid etching
• Multi-Unit: None. | • MPI: Sand alumina large grit
blasting and Acid etching. | • Sand alumina large grit
blasting and Acid
etching.
• Color using anodization
(Pink-Purple and Green)
of the tissue level
implant neck portion | Similar.
The color anodization of the tissue
level (neck portion) of the implant is
similar to the reference TRI implant.
The surface SLA treatment is
identical to K140728 and K161497,
except for the anodization colors. |
| Feature | - Subject Device -
TPI Implant | Primary Predicate Device
Ditron's Dental Implants
and Abutments [MPI,
OPI and Multi-Unit
Abutment] Cleared
under K140728 | Reference Device -Ditron's
Dental Implants and
Abutments [MPI L6.0mm
and Liberator] Cleared under
K161497 | Reference Device -
TRI Dental Implants'
TRI-matrix® Implant
Line [TRI-matrix®
Tissue-Level]
Cleared under K203660 | Substantial Equivalence
Discussion |
| | the tissue level implant
neck portion. | | | | to new questions of safety and
effectiveness. |
| Implant to
Abutment
Connection | One-Piece Implant, in
which the endosseous
and abutment portions
consist of one unit. | OPI: One-Piece implant, in
which the endosseous and
abutment portions consist of
one unit.
MPI: Ditron Dental Internal
Hexagon | Ditron Dental Internal Hexagon | N/A since the reference
device is used only for the
tissue level surface
treatment comparison | Similar, since Ditron's cleared OPI
implant includes the same one-piece
concept where the implant and
abutment are integrated. |
| Implant
Design | One-piece design with
tapered body (MPI
design integrated with
straight multi-unit
abutment) | • OPI: One-Piece design
with tapered body
• MPI: Two-piece model
design (implant and
abutments including angled
multi-unit abutment), with
tapered body | Two-piece MPI model design
(short implant and abutments
including straight multi-unit
abutment), with Tapered body | N/A since the reference
device is used only for the
tissue level surface
treatment comparison | Similar.
• Ditron's cleared OPI implant
includes the one-piece design with
tapered body.
• The TPI utilizes the same design as
the MPI when connected to a
straight multi-unit, serving as a
one-piece implant. Therefore, it is
fully covered under the existing
design of Ditron's implant models. |
| Interface
Type | Engaging | All: Engaging
Multi-Unit only:
non-Engaging | Engaging | N/A since the reference
device is used only for the
tissue level surface
treatment comparison | Identical to all engaging devices in
K140728 and K161497. |
| Prosthetic
Platforms | Straight TPI prosthetic
platform (Also referred
to as "Connection
Platform Cone"):
external hexalobular | Multi-Unit abutment
platform (angulated):
external hexagon | Multi-Unit abutment platform
(Straight): external hexagon | N/A since the reference
device is used only for the
tissue level surface
treatment comparison | Similar. No new questions of safety
and effectiveness. |
| Feature | - Subject Device -
TPI Implant | Primary Predicate Device
Ditron's Dental Implants
and Abutments [MPI,
OPI and Multi-Unit
Abutment] Cleared
under K140728 | Reference Device -Ditron's
Dental Implants and
Abutments [MPI L6.0mm
and Liberator] Cleared under
K161497 | Reference Device -
TRI Dental Implants'
TRI-matrix® Implant
Line TRI-matrix®
Tissue-Level]
Cleared under K203660 | Substantial Equivalence
Discussion |
| Implant
Diameter and
Length
Dimensions
(mm) | Ø3.3, Ø3.5 and
Ø3.75mm for lengths of
L8.0, 10, 11.5, 13 and
16mm
And;
Ø4.2 and Ø5.0mm for
lengths of: L6.0, 8.0, 10,
11.5, 13, 16mm. | MPI: Ø3.5mm, 3.75 mm,
4.2 mm, 5.0 mm and 6.0
mm for Lengths of: 8.0, 10,
11.5, 13 and 16 mm for
Lengths of: 8.0, 10, 11.5,
13and 16mm.
OPI: Ø3.0 and 3.3mm for
Lengths of: L8.0, 10, 11.5.
13 and 16mm. | MPI: OD=3.3mm for Lengths
of: L8.0, 10.0, 11.5. 13 and
16mm. OD=4.2, 5.0. 6.0 for
L=6.0mm. | N/A since the reference
device is used only for
the tissue level surface
treatment comparison | Similar. Dimensions fall under
existing range of dimensions. |
| Abutment
Diameter | TPI Implant Tissue level
element: Ø4.8mm
(refers to the integrated
straight multi-unit
abutment portion) | N/A. Since there is no
straight multi-unit abutment. | Ø4.8mm (Straight multi-unit
individual abutment) | N/A since the reference
device is used only for the
tissue level surface
treatment comparison | Identical to K161497 |
| Gingival
Height(s) | 3.0mm | N/A. Since there is no
straight multi-unit abutment. | N/A. Ø1.0, 2.0, 3.0, 4.0, and
5.0mm (individual straight
multi-unit abutment) | Gingival Heights, mm
1.8 mm | Identical to K161497 since
dimensions fall within the range of
the cleared straight multi-unit, which
is integrated in the TPI subject
device. |
| Shelf-life | 5 Years | 5 Years | 5 Years | 5 Years | Identical to all compared devices. |
| Sterilization
Method | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation | Identical to all compared devices. |
| Single use | Yes | Yes | Yes | Yes | Identical to all compared devices. |
| Feature | All Subject Abutments | - Primary Predicate Device -
Ditron's Dental Implants and
Abutments
[Multi-Unit Abutment] Cleared
under K140728 | - Reference Device -
Ditron's Dental Implants and
Abutments [Liberator]
Cleared under K161497 | - Reference Device -
TRI Dental Implants' TRI-
matrix® Implant Line [TRI-
matrix® Tissue-Level, Abutment
Screws]
Cleared under K203660 | Substantial
Equivalence
Discussion |
| Indications
for Use | As specified in Table 1 for each device (subject device, predicate device and reference device), since the indications for use statement
refers to both implants and abutments as an integral system. | | | | Identical to all
compared devices. |
| Patient
Population | Edentulous or partially
edentulous individuals | Edentulous or partially
edentulous individuals | Edentulous or partially
edentulous individuals | Edentulous and partially edentulous
individuals | Identical to all
compared devices. |
| Construction | Machined with or
without anodization | Machined | Machined | Machined with or without
anodization | Similar to all
compared devices |
| Material | Ti-6Al-4V-ELI | Ti-6Al-4V-ELI | Ti-6Al-4V-ELI | Ti-6Al-4V-ELI | Identical to all
compared devices. |
| Surface
Treatment | Healing Caps,
Prosthetic and Cover
Screws and optional for
all Ditron titanium
abutments: Color
Anodization (Blue,
Yellow-gold, Pink-
Purple and Green) | Multi-Unit abutment: none | Liberator: None | Implant: Pink anodized collar
(Tissue Level)
Abutment Screws: Gold anodized | Similar.
The anodization
of TRI's reference
device abutment's
tissue level (neck
portion) of the
implant and the
Abutment Screws
is similar to the
subject device. |
8
Image /page/8/Picture/0 description: The image contains the logo for Ditron Dental. The logo consists of a green abstract shape resembling a stylized letter "D" on the left, followed by the words "DITRON" and "DENTAL" stacked vertically on the right. The text is in a simple, sans-serif font and is black.
9
Image /page/9/Picture/0 description: The image shows the logo for Ditron Dental. The logo consists of a green geometric shape on the left, followed by the words "DITRON" and "DENTAL" stacked on top of each other. The word "DITRON" is on the top line, and the word "DENTAL" is on the bottom line.
Table 2: Table of Substantial Equivalence – Technological Characteristics - TPI Implants
10
Image /page/10/Picture/0 description: The image shows the logo for Ditron Dental. The logo consists of a green geometric shape resembling a stylized letter "D" on the left, followed by the words "DITRON" and "DENTAL" stacked vertically on the right. The text is in a simple, sans-serif font and is black.
11
Image /page/11/Picture/0 description: The image shows the logo for Ditron Dental. The logo consists of a green geometric shape on the left and the words "DITRON DENTAL" on the right. The word "DITRON" is stacked on top of the word "DENTAL".
12
Image /page/12/Picture/0 description: The image shows the logo for Ditron Dental. The logo consists of a green stylized letter D on the left, followed by the words "DITRON" on the top line and "DENTAL" on the bottom line. The text is in a simple, sans-serif font and is black.
Table 3: Table of Substantial Equivalence – Technological Characteristics - Abutments
Note: This part of the substantial equivalence table, summarizes the technological characteristics of the various abutments, and is divided to the mutual aspects relevant to all Ditron's abutments which are applicable to the TPI implant and its associated abutments, followed by each variation, identified and addressed by individually by its own, as follows:
13
Image /page/13/Picture/0 description: The image contains the logo for Ditron Dental. The logo consists of a green abstract shape on the left, resembling a stylized letter "D". To the right of the shape, the words "DITRON" and "DENTAL" are stacked vertically, with "DITRON" on top and "DENTAL" below. The text is in a simple, sans-serif font and is black.
| Feature | All Subject Abutments | - Primary Predicate Device -
Ditron's Dental Implants and
Abutments
[Multi-Unit Abutment] Cleared
under K140728 | - Reference Device -
Ditron's Dental Implants and
Abutments [Liberator]
Cleared under K161497 | - Reference Device -
TRI Dental Implants' TRI-
matrix® Implant Line [TRI-
matrix® Tissue-Level, Abutment
Screws]
Cleared under K203660 | Substantial
Equivalence
Discussion |
|---------------------------|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Sterilization
Method | Cover Screws:
Gamma Irradiation | Cover Screws:
Gamma Irradiation | Cover Screws:
Gamma Irradiation | Implant:
Gamma Irradiation | Identical to all
compared devices |
| | Other abutments:
Non-Sterile Provided | Other abutments:
Non-sterile provided | Other abutments:
Non-Sterile Provided | Abutment Screws:
Non-Sterile Provided | |
| End-User
Sterilization | Cover Screws:
Sterile Provided | Cover Screws:
Sterile Provided | Cover Screws:
Sterile Provided | Implants:
Sterile Provided | Identical to all
compared devices |
| | Other abutments:
Moist steam sterilization | Other abutments:
Moist steam sterilization | Other abutments:
Moist steam sterilization | Abutment Screws:
Moist steam sterilization | |
| Packaging | Cover Screws:
Packaged with implant. | Cover Screws:
Packaged with implant. | Cover Screws:
Packaged with implant. | N/A since the reference device is
used only for the tissue level surface
treatment comparison | identical to
K140728 and
K161497 |
| | Other abutments:
Prosthetic Pouch | Other abutments:
Prosthetic Pouch | Other abutments:
Prosthetic Pouch | | |
| Single use | Yes | Yes | Yes | Yes | Identical to all
compared devices |
14
Image /page/14/Picture/0 description: The image shows the logo for Ditron Dental. The logo consists of a green geometric shape on the left, resembling a stylized letter "D" or an abstract tooth. To the right of the shape, the words "DITRON" and "DENTAL" are stacked vertically in a sans-serif font. The overall design is clean and modern, conveying a sense of professionalism and innovation in the dental field.
Table 4: Table of Substantial Equivalence – Technological Characteristics - TPI Healing Cap
| Feature | TPI Healing Cap
Subject Device | MPI Healing Cap
Predicate Device
cleared under
K140728 | Substantial Equivalence Discussion |
|-------------------------|-----------------------------------------------------------|-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Healing Cap
Diameter | 4.8mm | 4.8mm | Identical to K140728 |
| Healing Cap
Height | 3.5, 4.5, 5.5mm | 4.5mm | Similar. The subject device includes
additional height dimensions which do not
lead to new questions of safety and
effectiveness. |
| Duration | 180 Days | 180 Days | Identical to K140728 |
| Shape | Cylindrical | Cylindrical | Identical to K140728 |
| Abutment
Connection | Straight TPI prosthetic platform:
external hexalobular | Ditron Dental Multi-
Unit Abutments:
external hexagon | Similar.
Minor differences in connection platform.
This change does not lead to new questions
of safety and effectiveness, since the
predicate device's connection has a similar
shape. Yet, the subject device adds a more
robust design due to the additional
hexalobular design (as elaborated in
Table 2). |
Table 5: Table of Substantial Equivalence – Technological Characteristics - TPI Titanium Copings
| Feature | TPI Titanium Copings
Abutment Subject Device | Temporary Titanium
Abutments Predicate
Device cleared under
K140728 | Substantial Equivalence Discussion |
|------------------------|----------------------------------------------------------------------------------|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Connection | Coping Abutment Bridges:
Non-Engaging.
Coping Abutment Crowns:
Engaging | Non-Engaging | Similar. No new questions of safety and
effectiveness |
| Diameter | 4.8mm | 4.8mm | Identical to K140728 |
| Height | Short Version L4.85mm
Long Version L11.0mm | 12.0mm | Similar. Slight difference in height that do not
lead to new questions of safety and
effectiveness |
| Shape | Cylindrical with retention
grooves | Cylindrical with
retention grooves | Identical to K140728 |
| Abutment
Connection | Straight TPI prosthetic
platform:
External hexalobular | Ditron Dental Multi-
Unit Abutments
platform: External
Hexagon | Similar. Minor differences in connection
platform. This change does not lead to new
questions of safety and effectiveness, since the
predicate device's connection has a similar |
15
Image /page/15/Picture/0 description: The image contains the logo for Ditron Dental. The logo consists of a green abstract shape on the left, resembling a stylized letter D. To the right of the shape are the words "DITRON" stacked on top of "DENTAL" in a simple sans-serif font. The overall design is clean and modern.
| Feature | TPI Titanium Copings
Abutment Subject Device | Temporary Titanium
Abutments Predicate
Device cleared under
K140728 | Substantial Equivalence Discussion |
|------------|-------------------------------------------------|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| | | | shape. Yet, the subject device adds a more
robust design due to the additional
hexalobular design (as elaborated in Table 2). |
| Angulation | 0° | 0° | Identical to K140728 |
Table 6: Table of Substantial Equivalence - Technological Characteristics - TPI Liberator Abutments
| Feature | TPI Liberator Abutments
Subject Device | Liberator Abutments Reference
Device cleared under K161497 | Substantial Equivalence
Discussion |
|---------------------|------------------------------------------------------------------|-------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Height | 3.5, 4.5, 5.5mm | 2.35, 3.35, 4.35, 5.35, 6.35mm | All dimensions are within the
range of the cleared device. |
| Shape | Cylindrical abutments for
overdentures attachment
system | Cylindrical abutments for
overdentures attachment system | Identical to K140728 |
| Surface Treatment | None | None | Identical to K140728 |
| Abutment Connection | Straight TPI prosthetic
platform with external
hexalobular | Ditron Dental Straight Multi-
Unit Abutments platform:
external Hexagon | Minor differences in
connection platform that do
not lead to new questions of
safety and effectiveness |
| Angulation | 0° | 0° | Identical to K161497 |
7. Non-clinical Performance Data:
The following non-clinical tests were performed in order to demonstrate the substantial equivalence of the additional TPI Dental Implants and Abutments:
- Biocompatibility: Biocompatibility evaluation and testing according to ISO 10993-1 ● Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity and ISO 10993-11 Biological evaluation of medical devices Part 11: Tests for systemic toxicity together with chemical characterization support the substantial equivalent of the subject device.
- Gamma Sterilization Validation: Gamma Sterilization was conducted to all . Ditron sterile provided items with accordance to ISO 11137-2 and AAMI TIR33 (replaced by ISO 13004:2022 with no changes affecting the original sterilization validation) using the VDmax method. All aspects of the Gamma sterilization process and tests remained unchanged as cleared under K140728. The sterilization results supported the SAL of at least 10-6.
16
Image /page/16/Picture/0 description: The image shows the logo for Ditron Dental. The logo consists of a green abstract shape resembling the letter 'D' on the left, followed by the words 'DITRON' and 'DENTAL' stacked on top of each other in a sans-serif font. The color of the text is black.
- Pyrogen Testing (Bacterial Endotoxin): Pyrogen testing is performed using LAL (Limulus . Amebocyte Lysate) method. The TPI is part of the routine quarterly LAL testing to comply with the testing limit of 20EU per device. The test is performed in accordance with ANSI/AAMI ST72 standard, USP and USP .
- Steam Sterilization Validation: Steam Sterilization was conducted to all Ditron abutments that are provided non-sterile and intended to be sterilized by the user at the clinic. The sterilization validation was conducted in accordance to ISO 17665 parts 1 and 2 and; ANSI AAMI ST79 using the overkill / half-cycle method. All aspects of the Steam sterilization validation process and tests remained unchanged as cleared under K140728. The steam sterilization validation results supported the SAL of at least 10-6.
- Surface testing: The implants' surface was evaluated by SEM scans and EDS analyses. All ● surface tests results met Ditron's specifications.
- Fatigue Testing: There has been no change in the final configuration of the Ditron Dental ● Implants and Abutments system configuration.
Being similar in dimensions to the primary predicate, the TPI provided in straight configuration only and in one-piece design, does not alter the worst-case scenario.
The fatigue tests cleared under K140728 were conducted using worst case configuration and with accordance to ISO 14801 and FDA Guidance document for Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. Since the previously conducted tests cover the additional TPI Implant and abutments, these tests were not repeated.
- Implant-Bone Contact Analysis (applicable for short implants with a length of 6.0mm): ● There has been no change in the surface contact, and therefore, these tests were not repeated.
- Implant Surface Area Analysis (applicable for short implants in length of 6.0mm): ● There has been no change in the surface area and therefore these tests were not repeated.
- Comparative pull-out test (applicable for short implants in length of 6.0mm): The previously . cleared MPI model was tested using a worst-case configuration and therefore no additional testing was conducted.
- Shelf life: Shelf life and package integrity along 5 years was validated previously within ● Ditron K140728 cleared products. This test was not repeated since all aspects of packaging and sterile barrier materials, process and process parameters are identical for all Ditron implants (subject devices and cleared devices) as cleared under K140728. ISO 11607-1 standard was followed in order to establish 5 years shelf life and package integrity. All tests met their acceptance criteria.
- MRI Compatibility: MRI Compatibility was established based on evaluation against . scientific literature (Woods et al., "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices") and product properties. It was concluded that the device is eligible to bear MR Conditional labeling.
17
Image /page/17/Picture/0 description: The image shows the logo for Ditron Dental. The logo consists of a green abstract shape resembling a stylized letter "D" on the left, followed by the words "DITRON" and "DENTAL" stacked vertically on the right. The text is in a simple, sans-serif font and is black in color.
Following the above-described tests and evaluations, it was concluded that the tested devices, whether conducted on the TPI itself or leveraged from Ditron's own discussed predicate devices, passed all tests and successfully met all acceptance criteria and tests' requirements.
8. Substantial Equivalence Conclusion:
The subject TPI dental implants and abutments have the same indications for use,
technological characteristics, mode of operation and performance specifications as the above identified predicate and reference devices. A predicate device for each difference was presented, Similarities and differences were addressed and discussed, and no safety or effectiveness questions were raised.
Based upon the comparison and information described above, Ditron Dental has concluded that its additional TPI dental implants and abutments are substantially equivalent to the discussed primary predicate and reference devices.