(149 days)
No
The summary describes physical dental implants and abutments and their mechanical properties and testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device, which includes dental implants and abutments, is intended to restore a patient's chewing function and provide support for prosthetic devices, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
Explanation: The provided text describes dental implants and abutments used for surgical and restorative applications to support prosthetic devices and restore chewing function. It does not mention any diagnostic capabilities for this device.
No
The device description clearly details physical dental implants and abutments made of titanium, which are hardware components. There is no mention of any software as the primary or sole component of the device.
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 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 therapeutic and structural purpose, not a diagnostic one.
- Device Description: The description details the physical characteristics and design of the implants and abutments, focusing on their mechanical and structural properties for placement in bone.
- Performance Studies: The performance studies focus on aspects like biocompatibility, sterilization, surface testing, fatigue testing, implant-bone contact, and shelf life. These are all relevant to the safety and efficacy of an implantable medical device, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the information provided strongly indicates that this device is a medical device intended for surgical implantation and not an in vitro diagnostic device.
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 model
The 3.3 and 3.0 mm 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.
MPI, ULT, API, CPI and OPI designs are indicated for immediate loading (except for MPI and API in 6mm length) when good primary stability is achieved and with appropriate occlusal loading.
MPI, ULT, API, CPI and OPI are indicated for immediate loading (except for MPI and API in 6mm length) in single tooth restorations when good primary stability is achieved with appropriate occlusal loading.
The 30-degree multi-unit abutments shall be used within 45 degrees of parallelism for a splinted restoration. The 17-degree multi-unit abutments shall 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 the changes related to Ditron's dental implants and abutments. The addition of more products' variations is to offer dental surgeons additional implant options for patient treatment.
The requested additions to Ditron's Dental Implants and Abutments within this 510(k) are hereby described:
. Modification to the MPI Model -
The MPI features an expanding tapered implant body with double-thread selftapping design to gradually condense the bone.
The MPI model remained the same as cleared under K140727 except for the following modifications:
Length: 6mm (only with diameter of 4.2mm, 5.0mm and 6.0mm), Diameters: 3.3 (with lengths 8.0mm, 10mm, 11.5mm, 13mm and 16mm). The 'groove' between thread leads which is part of the MPI design in all dimension variations, was removed only at the OD 3.3mm design.
All MPI dimensions are detailed in section 7 of this 510(k) summary.
An additional implant type: ULT (Ultimate) -.
The ULT design is based on Ditron's cleared MPI model. The ULT features an expanding tapered implant body and a truncated-cone profile provides root-form morphology of the tooth root.
The implant has a self-tapping design and micro threads at the top of the implant. All ULT implant dimensions are detailed in section 7 of this 510(k) summary.
An additional implant type: API (Advanced Precision Implants) -●
The API design is based on Ditron's cleared MPI model. The API features an expanding tapered implant body with double-thread self-tapping implant body and apex design. The design is intended for subcrestal placement.
The implant beveled collar shifts the implant-abutment junction inward, in order to achieve platform-switching configuration. Only the 6mm API model includes a 'groove' while the others do not. All API implant dimensions are detailed in section 7 of this 510(k) summary.
An additional Abutment type: Milled Abutment -
The Milled Abutment design is based on Ditron's cleared Straight Abutments. The Milled Abutment allows the dentist to produce customized abutments (no additional angular correction).
No CAD/CAM design and fabrication is allowed for the Milled Abutment models. Only hand-milling or casting may be used for abutment modification.
An additional Abutment type: Liberator Abutment -
The Liberator Abutment is an overdenture retention abutment. Its design is based on Ditron's cleared Ball Attachments. The Liberator abutments are used for tissue and implant support of overdentures. Typically with two or more relatively parallel implants. Liberator overdenture retention abutments provide firm retention and stabilization to the overdenture.
The Liberator Abutment is available is several length dimensions of 0.5, 1.0, 2.0, 3.0, 4.0 and 5.0mm.
Straight Multi-Unit Abutment -
Additional two lengths were added to Ditron's cleared Straight Multi-Unit abutments. These length dimensions are: 4.0mm and 5.0mm. All dimensions' variations of the straight Multi-Unit abutments are detailed in section 7 of this 510(k) summary.
All above described implants and abutments are made of biocompatible 6A1-4V-ELI Titanium grade.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the upper or lower jaw
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance data:
- Biocompatibility - Biocompatibility was established within Ditron 510(k) K140728 using the device chemical and biological tests. No changes took place in terms of the body contact 6A1-4V-ELI Titanium grade. The Cytotoxicity test was supported with chemical characterization tests utilizing exaggerated extractions conditions using three extracts and leachables/extractables analyses using acceptable methods (GC-MS, XPS). All tests were completed with satisfactory results. The tests were conducted with accordance to ISO 10993-1 and FDA Guidance for biological evaluation.
- Gamma Sterilization Validation - Gamma Sterilization validation was conducted to all Ditron sterile provided items with accordance to ISO 11137-2 and AAMI TIR33 using the VDmax method. All aspects of the Gamma sterilization validation process and tests remained unchanged as cleared under K140728. The sterilization validation results supported the SAL of at least 10-6.
- Steam Sterilization Validation - Steam Sterilization validation 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 with 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 10-9.
- Surface testing - The implants' surface was tested within previous cleared 510(k) by SEM/EDS and XPS tests. All surface tests results met Ditron's specifications. Since there was no change in the surface treatment process, these tests were not repeated.
- Fatigue Testing - The modified subject products' were tested for Fatigue as follows:
a) MPI Fatigue test report (OD 3.3mm implant with 25° abutment) covering the API as well.
b) ULT Fatigue test report (OD 3.5mm implant with 25° abutment).
The previously cleared MPI model was tested for fatigue using worst case configuration of OD3.5mm and 30° multi-unit abutment within Ditron's cleared K140728 covering the cleared CPI model as well. The fatigue tests were conducted using worst case configuration considering the highest angulation as well as smallest diameter and wall thickness. The tests were conducted with accordance to ISO 14801 and FDA Guidance document for Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. The results met the test's requirements. - Implant-Bone Contact Analysis - Contact surface area was analyzed in comparison to legally marketed device.
- Implant Surface Area Analysis - Implant actual surface area before surface treatment was compared to the predicate device.
- Comparative pull-out test of Ditron smallest implant with legally marketed device.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three overlapping profiles facing to the right. The profiles are black and create a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 28, 2016
Ditron Precision Ltd. % Tali Hazan Regulatory Consultant Talmed Ltd. Ramot Naftali, M.P Upper Galillee Ramot Naftali, 13830000 ISRAEL
Re: K161497
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: September 25, 2016 Received: October 3, 2016
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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
1
with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161497
Device Name
Dental Implants and Abutments
Implants' subtypes: MPI - Molecular Precision Implant, ULT - Ultimate, API - Advanced Precision Implant, CPI - Cylindrical Precision Implant, OPI - One Piece Implant.
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 model
The 3.3 and 3.0 mm diameter models for One stage OPI, Two stage and API implants are intended only for the incisors and cuspids of the maxilla and mandible. They are also indication 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.
MPI, ULT. API, CPI and OPI designs are indicated for immediate loading (except for MPI and API in 6mm length) when good primary stability is achieved and with appropriate occlusal loading.
MPI, ULT, API, CPI and OPI are indicated for immediate loading (except for MPI and API in 6mm 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) 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.
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Image /page/3/Picture/1 description: The image contains the logo for Ditron Precision. The logo consists of a red, geometric shape on the left, resembling a stylized letter D or an abstract symbol. To the right of the shape is the word "DITRON" in bold, black capital letters. Below "DITRON" is the word "PRECISION" in a smaller, black font, also in capital letters.
דיטרון תעשיות בע"מ, ת.ד. 5010, אשקלון 78150 רח' האופה 2, אזור התעשיה הדרומ אשקלון 070 | 09-6711841 70
Image /page/3/Picture/3 description: The image shows a logo with the text "nqa" in a white circle at the top. Below the circle, the text "TS 16949" is displayed in a bold, sans-serif font. The word "Registered" is written below "TS 16949". The logo appears to be a certification mark, possibly related to quality management systems.
.ditronprecision.com
510(K) Summary for
Ditron's Dental Implants and Abutments
- Date Prepared: October 22, 2016 1.
2. 510(k) owner name:
| Company name: | Ditron Precision Ltd. |
|---|---|
| Address: | 2 Haofe St |
| Ashkelon, 78150 | |
| Israel | |
| Phone: | +972-8-6711841 |
| Fax: | +972-9-6711843 |
| E-mail: | orlev@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 |
| Fax: | +972-(0)722448981 |
| E-mail: | tali.hazan@talmed.co.il |
4
Image /page/4/Picture/1 description: The image shows the logo for Ditron Precision. The logo features the company name in bold, black letters, with the word "DITRON" appearing larger than the word "PRECISION" which is placed underneath. To the left of the company name is a red, triangular shape. The image also contains some Hebrew text and numbers, specifically "781" and "08-".
דיטרון תעשיות בע"מ, ת.ד. 5010, אשקלון 78150
רח' האופה 2, אזור התעשיה הדרומי, אשקלון
08-6711841.70 | פק08-6711843 פקס
Image /page/4/Picture/3 description: The image shows a logo with the text "nqa. TS 16949 Registered". The logo is black and white and appears to be a certification mark. The text is stacked vertically, with "nqa." at the top, followed by "TS 16949" and "Registered" at the bottom.
Device Name and Classification: 3.
Common or usual name: Dental Implants and Abutments Proprietary/Trade name: Dental Implants and Abutments Implants' subtypes: MPI - Molecular Precision Implant;
ULT - Ultimate Precision Implant; API - Advanced Precision Implant;
CPI - Cylindrical Precision Implant; OPI - One Piece Implant.
Classification name Ditron Dental Implants and Abutments have been classified as Class II devices under the following classification names:
| Classification Name | 21 CFR Ref. | Product Code | Panel |
|---|---|---|---|
| Endosseous Dental Implant | 872.3640 | Primary: | |
| DZE | DAGRID, | ||
| Dental | |||
| Secondary: | |||
| NHA |
4. Predicate Device:
The devices within this submission are substantially equivalent to the following predicate devices:
- Ditron Precision Ltd's legally marketed Dental Implants and Abutments, cleared . under 510(k) number K140728 (primary predicate device), and;
- . MIS Implants Technologies Ltd's MIS Short Implants (SEVEN), cleared under 510(k) number K103089 (reference predicate device).
- . Implant Direct LLC's Legacy3 6mm Length implants, cleared under 510(k) number K131097 (reference predicate device).
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Image /page/5/Picture/1 description: The image shows the logo for Ditron Precision. The logo consists of a red, stylized hexagon on the left, followed by the word "DITRON" in bold, black letters. Below "DITRON" is the word "PRECISION" in a smaller, black font. The logo is simple and modern, with a focus on the company name.
דיטרון תעשיות בע"מ, ת.ד. 5010, אשקלון 78150
רח' האופה 2, אזור התעשיה הדרומי, אשקלון
08-6711841.70 פק08-6711843 פקס
Image /page/5/Picture/3 description: The image contains a logo with the text 'ngs. TS 16949 Registered'. The logo is circular and contains the text in a stacked format. The text 'ngs' is at the top, followed by 'TS 16949' and 'Registered' at the bottom. The text is in a sans-serif font and is black against a white background.
ട. Device description:
This submission covers the changes related to Ditron's dental implants and abutments. The addition of more products' variations is to offer dental surgeons additional implant options for patient treatment.
The requested additions to Ditron's Dental Implants and Abutments within this 510(k) are hereby described:
. Modification to the MPI Model -
The MPI features an expanding tapered implant body with double-thread selftapping design to gradually condense the bone.
The MPI model remained the same as cleared under K140727 except for the following modifications:
Length: 6mm (only with diameter of 4.2mm, 5.0mm and 6.0mm), Diameters: 3.3 (with lengths 8.0mm, 10mm, 11.5mm, 13mm and 16mm). The 'groove' between thread leads which is part of the MPI design in all dimension variations, was removed only at the OD 3.3mm design.
All MPI dimensions are detailed in section 7 of this 510(k) summary.
An additional implant type: ULT (Ultimate) -.
The ULT design is based on Ditron's cleared MPI model. The ULT features an expanding tapered implant body and a truncated-cone profile provides root-form morphology of the tooth root.
The implant has a self-tapping design and micro threads at the top of the implant. All ULT implant dimensions are detailed in section 7 of this 510(k) summary.
- An additional implant type: API (Advanced Precision Implants) -●
The API design is based on Ditron's cleared MPI model. The API features an expanding tapered implant body with double-thread self-tapping implant body and apex design. The design is intended for subcrestal placement.
The implant beveled collar shifts the implant-abutment junction inward, in order to achieve platform-switching configuration. Only the 6mm API model includes a 'groove' while the others do not. All API implant dimensions are detailed in section 7 of this 510(k) summary.
6
●
Image /page/6/Picture/1 description: The image shows the logo for Ditron Precision. The logo features a red, hexagonal shape on the left, followed by the word "DITRON" in bold, black letters. Below "DITRON" is the word "PRECISION" in a smaller, sans-serif font.
דיטרון תעשיות בע"מ, ת.ד. 5010, אשקלון 78150
רח' האופה 2, אזור התעשיה הדרומי, אשקלון
08-6711841.0 | 08-671184307 פקס
Image /page/6/Picture/3 description: The image shows a logo with the text "nqa." on the top. Below that, the text "TS 16949 Registered" is displayed. The logo is black and white and appears to be a certification mark.
An additional Abutment type: Milled Abutment -
The Milled Abutment design is based on Ditron's cleared Straight Abutments. The Milled Abutment allows the dentist to produce customized abutments (no additional angular correction).
No CAD/CAM design and fabrication is allowed for the Milled Abutment models. Only hand-milling or casting may be used for abutment modification.
● An additional Abutment type: Liberator Abutment -
The Liberator Abutment is an overdenture retention abutment. Its design is based on Ditron's cleared Ball Attachments. The Liberator abutments are used for tissue and implant support of overdentures. Typically with two or more relatively parallel implants. Liberator overdenture retention abutments provide firm retention and stabilization to the overdenture.
The Liberator Abutment is available is several length dimensions of 0.5, 1.0, 2.0, 3.0, 4.0 and 5.0mm.
● Straight Multi-Unit Abutment -
Additional two lengths were added to Ditron's cleared Straight Multi-Unit abutments. These length dimensions are: 4.0mm and 5.0mm. All dimensions' variations of the straight Multi-Unit abutments are detailed in section 7 of this 510(k) summary.
All above described implants and abutments are made of biocompatible 6A1-4V-ELI Titanium grade.
Intended use: 6.
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
7
Ditron Precision Ltd, P.O.B. 5010, Ashkelon 78150, Israel
2 Haofe St. Southern Ind. Zone, Ashkelon 78780, Israel
Tel: +972-8-6711841 | Fax: +972-8-6711843
Image /page/7/Picture/1 description: The image shows the logo for Ditron Precision. The logo features a red, stylized hexagon on the left, followed by the word "DITRON" in bold, black letters. Below "DITRON" is the word "PRECISION" in a smaller, sans-serif font, also in black. The overall design is clean and modern.
דיטרון תעשיות בע"מ, ת.ד. 5010, אשקלון 78150
רח' האופה 2, אזור התעשיה הדרומי, אשקלון
08-6711841.70 פק08-6711843.0 פקס
Image /page/7/Picture/3 description: The image contains a logo with the text "ngs" at the top, followed by "TS 16949 Registered". The logo is set against a black background, with the text in white. The overall design is simple and conveys a sense of certification or registration.
itronprecision.com
TS
RoHS
The 3.3 and 3.0 mm 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.
MPI, ULT, API, CPI and OPI designs are indicated for immediate loading (except for MPI and API in 6mm length) when good primary stability is achieved and with appropriate occlusal loading.
MPI, ULT, API, CPI and OPI are indicated for immediate loading (except for MPI and API in 6mm length) in single tooth restorations when good primary stability is achieved with appropriate occlusal loading.
The 30-degree multi-unit abutments shall be used within 45 degrees of parallelism for a splinted restoration. The 17-degree multi-unit abutments shall be used within 32 degrees of parallelism for a splinted restoration.
7. Technological characteristics and Substantial Equivalence:
The subjected devices are substantially equivalent with Ditron's original Dental Implants and Abutments that were cleared under K140728 and MIS short implants, that were cleared under K103089, as identified above under 'predicate devices' section. A certain difference in the MPI collar design versus MIS 'SEVEN' short implant was covered under Implant Direct Legacy3 implant that was cleared under 510(k) number K131097.
Two differences exist between the subject device and the primary predicate device indications for use statement. These differences are only related to the additional twostage implant models (Ultimate and API) and to the 6mm length implants (MPI and API)
8
Image /page/8/Picture/1 description: The image shows the logo for Ditron Precision. The logo consists of a red hexagon on the left, followed by the word "DITRON" in black, bold letters. Below "DITRON" is the word "PRECISION" in smaller, black letters. The logo is simple and modern, and the use of red and black gives it a strong visual impact.
דיטרון תעשיות בע"מ, ת.ד. 5010, אשקלון 8150 רח' האופה 2, אזור התעשיה הדרומי. 079 | 08-6711841 70
Image /page/8/Picture/3 description: The image shows a logo with the text "nqa. TS 16949 Registered" inside a black square. The text is arranged in a stacked format, with "nqa." at the top, followed by "TS 16949" and then "Registered" at the bottom. The background of the logo is white, providing contrast to the black text and border.
litronprecision.com
TS 16949
Registered
being excluded from the immediate loading claims. Other than these differences the indications for use are identical. The differences are not affecting the intended use since the new subject devices are meant to be used the same way as the primary predicate device. The exclusion of the immediate loading for the 6mm length implants only narrows the primary predicate device intended use, thus do not raise additional concerns.
Both modified and predicate devices have the same indications for use, same shape, design and characteristics. All changes differ the new device from the predicate devices were addressed and evaluated.
| Feature | Ditron Dental Implants
and Abutments Predicate
Device cleared under
K140728 | MIS SEVEN Implants
Predicate Device cleared
under K103089 | Subject Ditron
Dental Implants and
Abutments
- Subject Device - |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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, 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 | MIS dental implants are
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. When a one stage
surgical procedure is
applied, the implant may be
immediately loaded when
good primary stability is
achieved and the occlusal
load is appropriate. MIS
short implants are to be
used only with straight
abutments. | 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 3.0 mm 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 |
| Feature | Ditron Dental Implants
and Abutments Predicate
Device cleared under
K140728 | MIS SEVEN Implants
Predicate Device cleared
under K103089 | Subject Ditron
Dental Implants and
Abutments
- Subject Device - |
| | 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, CPI and OPI designs
are indicated for immediate
loading when good primary
stability is achieved and with
appropriate occlusal loading.
MPI, CPI and OPI are
indicated for immediate
loading in single tooth
restorations when good
primary stability is achieved
with appropriate occlusal
loading.
The 30-degree multi-unit
abutments shall be used
within 45 degrees of
parallelism for a splinted
restoration. The 17-degree
multi-unit abutments shall be
used within 32 degrees of
parallelism for a splinted
restoration. | 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 and OPI
designs are indicated for
immediate loading (except for
MPI and API in 6mm length)
when good primary stability is
achieved and with appropriate
occlusal loading.
MPI, ULT, API, CPI and OPI
are indicated for immediate
loading (except for MPI and API
in 6mm length) in single tooth
restorations when good primary
stability is achieved with
appropriate occlusal loading.
The 30-degree multi-unit
abutments shall be used within
45 degrees of parallelism for a
splinted restoration. The 17-
degree multi-unit abutments
shall be used within 32 degrees
of parallelism for a splinted
restoration. | 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 and OPI designs are indicated for immediate loading (except for MPI and API in 6mm length) when good primary stability is achieved and with appropriate occlusal loading. MPI, ULT, API, CPI and OPI are indicated for immediate loading (except for MPI and API in 6mm length) in single tooth restorations when good primary stability is achieved with appropriate occlusal loading. The 30-degree multi-unit abutments shall be used within 45 degrees of parallelism for a splinted restoration. The 17-degree multi-unit abutments shall be used within 32 degrees of parallelism for a splinted restoration. |
| Material | Titanium 6Al-4V-ELI | Titanium 6Al-4V-ELI | Titanium 6Al-4V-ELI |
| Patient
Population | Edentulous or partially
edentulous individuals | Same population | Edentulous or partially
edentulous individuals |
| Implant
Models | MPI | MIS Short Implants
(SEVEN) | MPI, ULT, API |
| Dimensions
of two stage
implants | OD= 3.5mm, 3.75 mm, 4.2
mm, 5.0 mm for L= 8.0
mm, 10 mm, 11.5 mm, 13
mm and 16 mm.
OD= 6.0 mm for L=8.0
mm, 10 mm, 11.5 mm and
13 mm. | OD = 4.2, 5.0, 6.0 mm
L = 6 mm | MPI
OD=3.3 for L=8.0, 10.0,
11.5. 13 and 16 mm.
OD=4.2, 5.0. 6.0 for L=6mm.
ULT
OD=3.5, 3.75, 4.2, 5.0, 6.0
mm for L = 7.0, 8.0 10.0, |
| Feature | Ditron Dental Implants
and Abutments Predicate
Device cleared under
K140728 | MIS SEVEN Implants
Predicate Device cleared
under K103089 | Subject Ditron
Dental Implants and
Abutments - Subject Device - |
| | | | 11.5 13, 16mm
API
OD=3.3, 3.5 3.75, 4.2, 5.0,
6.0mm for L=8, 10,
11.5,13.16
OD=4.2, 5.0 mm for L=6, 8,
10, 11.5,13, 16.
OD=6.0 mm for L=6, 8, 10,
11.5, 13, 16. |
| Surface | Sand blasting & acid
etching | Sand blasting & acid
etching | Sand blasting & acid etching |
| Design | Conical screw | Conical screw | Conical screw |
| Sterilization | Sterile: Gamma | Sterile | Sterile: Gamma |
| Placement | Placing the implant
immediately after drilling | Same | Placing the implant
immediately after drilling |
| method | | | |
| Self-tapping | Yes | Yes | Yes |
| Connection
type | Internal hex | Internal Hex | Internal hex |
| Maximum
Abutment
Angle | 30° | Straight only | 30° for all implants except
for: Implants with L=6mm:
straight abutment only, and;
Implants with OD of less than
3.75mm: Up-to 25°
abutments only. |
The implants substantial equivalence table is following presented:
9
Image /page/9/Picture/1 description: The image contains the logo for Ditron Precision. The logo features a red, stylized geometric shape on the left, resembling a partial hexagon or an abstract letter 'D'. To the right of this shape, the word "DITRON" is written in a bold, sans-serif font. Below "DITRON", the word "PRECISION" is written in a smaller, lighter font.
דיטרון תעשיות בע"מ, ת.ד. 5010, אשקלון 78150 רח' האופה 2, אזור התעשיה הדרומי, אשקלון טל. 184118411841 | פקס. 08-6711841
Image /page/9/Picture/3 description: The image shows a logo with the text "nqa. TS 16949 Registered" inside a black square. The text is arranged in three lines, with "nqa." at the top, "TS 16949" in the middle, and "Registered" at the bottom. Above the text, there is a white circle.
10
Image /page/10/Picture/1 description: The image shows the logo for Ditron Precision. The logo consists of a red hexagon on the left, followed by the word "DITRON" in bold, black letters. Below "DITRON" is the word "PRECISION" in smaller, black letters. The logo is simple and modern, and the use of red and black gives it a strong and professional look.
דיטרון תעשיות בע"מ, ת.ד. 5010, אשקלון 78150 רח' האופה 2, אזור התעשיה הדרומי, אשקלון טל. 184118411841 | פקס. 08-6711841
Image /page/10/Picture/3 description: The image shows a logo with the text "nqa. TS 16949 Registered". The logo is black and white and has a square border. The text is in a sans-serif font and is stacked on top of each other.
11
Image /page/11/Picture/1 description: The image shows the logo for Ditron Precision. The logo consists of a red, stylized hexagon on the left, followed by the word "DITRON" in bold, black letters. Below "DITRON" is the word "PRECISION" in a smaller, thinner font, also in black. The logo is simple and modern, with a focus on the company name.
דיטרון תעשיות בע"מ, ת.ד. 5010, אשקלון 78150 רח' האופה 2, אזור התעשיה הדרומי, אשקלון טל. 08-6711841 | פקס. 08-6711841
w.ditronprecision.com
Image /page/11/Picture/4 description: The image shows a logo with the text "nqa. TS 16949 Registered" inside a square. The text is arranged in three lines, with "nqa." at the top, "TS 16949" in the middle, and "Registered" at the bottom. The "nqa." text is inside a circle.
Image /page/11/Picture/5 description: The image contains a logo for "DR. RUN DENTAL". The logo consists of a green square on the left and the text "DR. RUN DENTAL" on the right. The text is in a simple, sans-serif font and is stacked vertically, with "DR. RUN" on top and "DENTAL" below.
The Abutments substantial equivalence table is following presented:
| Subject Abutments compared with Abutments Cleared
| under K140728 | ||||
|---|---|---|---|---|
| Ditron P/N | Ditron | |||
| Abutment | ||||
| Name | ||||
| (*Made of | ||||
| Ti 6Al-4V-ELI) | Ditron Abutment | |||
| Family Description | Ditron Model | |||
| Name | Ditron Predicate | |||
| Device Model | ||||
| *Made of | ||||
| Ti 6Al-4V-ELI | ||||
| ABT-MILL | Anatomic | |||
| straight | ||||
| abutment with | ||||
| shoulder | Anatomic straight | |||
| abutment with shoulder | ||||
| 6 mm. length | Anatomic straight | |||
| abutment with | ||||
| shoulder | ABT-6050-2 | |||
| Straight | ||||
| Abutment | ||||
| MUA-10ST | Straight multi- | |||
| unit Bar retained | ||||
| abutment | Straight multi-unit Bar | |||
| retained abutment 1.0 | ||||
| mm. length | Straight multi-unit | |||
| Bar retained | ||||
| abutment | BAR-9005 | |||
| Straight multi- | ||||
| unit Bar retained | ||||
| abutment | ||||
| MUA-20ST | Straight multi- | |||
| unit Bar retained | ||||
| abutment | Straight multi-unit Bar | |||
| retained abutment 2.0 | ||||
| mm length | Straight multi-unit | |||
| Bar retained | ||||
| abutment | BAR-9015 | |||
| Straight multi- | ||||
| unit Bar retained | ||||
| abutment | ||||
| MUA-30ST | Straight multi- | |||
| unit Bar retained | ||||
| abutment | Straight multi-unit Bar | |||
| retained abutment 3.0 | ||||
| mm length | Straight multi-unit | |||
| Bar retained | ||||
| abutment | BAR-9025 | |||
| Straight multi- | ||||
| unit Bar retained | ||||
| abutment | ||||
| MUA-40ST | Straight multi- | |||
| unit Bar retained | ||||
| abutment | Straight multi-unit Bar | |||
| retained abutment 4.0 | ||||
| mm length | Straight multi-unit | |||
| Bar retained | ||||
| abutment | BAR-9025 | |||
| Straight multi- | ||||
| unit Bar retained | ||||
| abutment | ||||
| MUA-50ST | Straight multi- | |||
| unit Bar retained | ||||
| abutment | Straight multi-unit Bar | |||
| retained abutment 5.0 | ||||
| mm length | Straight multi-unit | |||
| Bar retained | ||||
| abutment | BAR-9025 | |||
| Straight multi- | ||||
| unit Bar retained | ||||
| Subject Abutments compared with Abutments Cleared | ||||
| under K140728 | ||||
| Ditron P/N | Ditron | |||
| Abutment | ||||
| Name | ||||
| (*Made of | ||||
| Ti 6Al-4V-ELI) | Ditron Abutment | |||
| Family Description | Ditron Model | |||
| Name | Ditron Predicate | |||
| Device Model | ||||
| *Made of | ||||
| Ti 6Al-4V-ELI | ||||
| LIB-ABT05 | Liberator | |||
| overdenture | ||||
| retention | ||||
| abutment | Liberator overdenture | |||
| retention abutment 0.5 | ||||
| mm length | Liberator | |||
| overdenture | ||||
| retention abutment | BAL-10005 | |||
| Ball attachment | ||||
| abutment | ||||
| LIB-ABT10 | Liberator | |||
| overdenture | ||||
| retention | ||||
| abutment | Liberator overdenture | |||
| retention abutment 1.0 | ||||
| mm length | Liberator | |||
| overdenture | ||||
| retention abutment | BAL-10005 | |||
| Ball attachment | ||||
| abutment | ||||
| LIB-ABT20 | Liberator | |||
| overdenture | ||||
| retention | ||||
| abutment | Liberator overdenture | |||
| retention abutment 2.0 | ||||
| mm length | Liberator | |||
| overdenture | ||||
| retention abutment | BAL-10020 | |||
| Ball attachment | ||||
| abutment | ||||
| LIB-ABT30 | Liberator | |||
| overdenture | ||||
| retention | ||||
| abutment | Liberator overdenture | |||
| retention abutment 3.0 | ||||
| mm length | Liberator | |||
| overdenture | ||||
| retention abutment | BAL-10030 | |||
| Ball attachment | ||||
| abutment | ||||
| LIB-ABT40 | Liberator | |||
| overdenture | ||||
| retention | ||||
| abutment | Liberator overdenture | |||
| retention abutment 4.0 | ||||
| mm length | Liberator | |||
| overdenture | ||||
| retention abutment | BAL-10040 | |||
| Ball attachment | ||||
| abutment | ||||
| LIB-ABT50 | Liberator | |||
| overdenture | ||||
| retention | ||||
| abutment | Liberator overdenture | |||
| retention abutment 5.0 | ||||
| mm length | Liberator | |||
| overdenture | ||||
| retention abutment | BAL-10050 | |||
| Ball attachment | ||||
| abutment | ||||
| Subject Abutments compared with Abutments Cleared | ||||
| under K140728 | ||||
| Ditron P/N | Ditron | |||
| Abutment | ||||
| Name | ||||
| (*Made of | ||||
| Ti 6Al-4V-ELI) | Ditron Abutment | |||
| Family Description | Ditron Model | |||
| Name | Ditron Predicate | |||
| Device Model | ||||
| *Made of | ||||
| Ti 6Al-4V-ELI | ||||
| LIB-ABT60 | Liberator | |||
| overdenture | ||||
| retention | ||||
| abutment | Liberator overdenture | |||
| retention abutment 6.0 | ||||
| mm length | Liberator | |||
| overdenture | ||||
| retention abutment | BAL-10060 | |||
| Ball attachment | ||||
| abutment |
12
Image /page/12/Picture/1 description: The image shows the logo for Ditron Precision. The logo consists of a red hexagon-like shape on the left, followed by the word "DITRON" in bold, black letters. Below "DITRON" is the word "PRECISION" in a smaller, less bold font. The overall design is clean and modern.
דיטרון תעשיות בע"מ, ת.ד. 5010, אשקלון 78150 רח' האופה 2, אזור התעשיה הדרומי, אשקלון טל. 184118411841 | פקס. 08-6711841
Image /page/12/Picture/3 description: The image shows a logo with the text 'nga.' on top of 'TS 16949 Registered'. The logo is black and white and appears to be a certification mark. The text is stacked vertically within a square border.
13
Image /page/13/Picture/1 description: The image shows the logo for Ditron Precision. The logo consists of a red, geometric shape on the left, resembling a stylized arrow or chevron. To the right of the shape, the word "DITRON" is written in bold, black letters, with the word "PRECISION" in a smaller font size underneath it.
דיטרוו מעשיות רעימ ת ב 10 רח' האופה 2.
Image /page/13/Picture/3 description: The image shows a logo with a black square background. Inside the square, there is a white circle at the top, containing the letters 'nqa.' Below the circle, there are three lines of text: 'TS 16949,' 'Registered,' and another line of text that is not fully legible due to the image quality. The logo appears to be a certification mark, possibly related to quality management standards.
Image /page/13/Picture/4 description: The image shows the logo for Ditron Dental. The logo has a green square on the left side. To the right of the square, the words "DITRON" and "DENTAL" are stacked on top of each other. The text is in a sans-serif font and is light gray.
Non-clinical performance data: 8.
The following non-clinical tests were performed in order to assure the safety and effectiveness of the modified devices:
-
Biocompatibility - Biocompatibility was established within Ditron 510(k) K140728 using the device chemical and biological tests. No changes took place in terms of the body contact 6A1-4V-ELI Titanium grade.
The Cytotoxicity test was supported with chemical characterization tests utilizing exaggerated extractions conditions using three extracts and leachables/extractables analyses using acceptable methods (GC-MS, XPS). All tests were completed with satisfactory results. The tests were conducted with accordance to ISO 10993-1 and FDA Guidance for biological evaluation. -
Gamma Sterilization Validation Gamma Sterilization validation was . conducted to all Ditron sterile provided items with accordance to ISO 11137-2 and AAMI TIR33 using the VDmax method. All aspects of the Gamma sterilization validation process and tests remained unchanged as cleared under K140728. The sterilization validation results supported the SAL of at least 10-6.
14
Image /page/14/Picture/1 description: The image shows the logo for Ditron Precision. The logo features a red hexagon on the left side, followed by the word "DITRON" in bold, black letters. Below "DITRON" is the word "PRECISION" in smaller, black letters. The logo is simple and modern, with a focus on the company name.
דיטרון מעשיות בע"מ ת ד
Image /page/14/Picture/3 description: The image shows a logo with the text "nqa." at the top of a circle. Below the circle, the text "TS 16949 Registered" is displayed in a stacked format. The logo appears to be a certification mark, possibly indicating that an organization is registered under the TS 16949 standard, which is related to quality management systems for automotive production.
Image /page/14/Picture/4 description: The image shows the text "vitronprecision.com". The text is in a sans-serif font and is black. The background is white. The text is slightly blurred. The image also contains a small, unidentifiable graphic to the right of the text.
- . Steam Sterilization Validation - Steam Sterilization validation 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 with 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 10-9.
- Surface testing The implants' surface was tested within previous cleared ● 510(k) by SEM/EDS and XPS tests. All surface tests results met Ditron's specifications. Since there was no change in the surface treatment process, these tests were not repeated.
- Fatigue Testing The modified subject products' were tested for Fatigue as ● follows:
- a) MPI Fatigue test report (OD 3.3mm implant with 25° abutment) covering the API as well.
- b) ULT Fatigue test report (OD 3.5mm implant with 25° abutment).
The previously cleared MPI model was tested for fatigue using worst case configuration of OD3.5mm and 30° multi-unit abutment within Ditron's cleared K140728 covering the cleared CPI model as well.
The fatigue tests were conducted using worst case configuration considering the highest angulation as well as smallest diameter and wall thickness.
The tests were conducted with accordance to ISO 14801 and FDA Guidance document for Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. The results met the test's requirements.
- Implant-Bone Contact Analysis Contact surface area was analyzed in . comparison to legally marketed device.
- Implant Surface Area Analysis Implant actual surface area before surface . treatment was compared to the predicate device.
15
Image /page/15/Picture/1 description: The image shows the logo for Ditron Precision. The logo features a red, stylized shape resembling a gear or a stylized letter 'D' on the left. To the right of the shape is the word "DITRON" in bold, black letters. Below "DITRON" is the word "PRECISION" in smaller, black letters.
דיטרון תעשיות בע"מ, ת.ד. 5010, אשקלון 78150
רח' האופה 2, אזור התעשיה הדרומי, אשקלון
08-6711841.טל | פקס: 08-6711843
Image /page/15/Picture/3 description: The image shows a logo with the text 'nqa.' inside a circle. Below the circle, the text 'TS 16949' is displayed, followed by the word 'Registered'. The logo appears to be a certification mark, possibly indicating compliance with the TS 16949 standard, which is related to quality management systems for automotive production.
- . Comparative pull-out test of Ditron smallest implant with legally marketed device.
- . 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.
Following the above described tests it was concluded that the tested devices passed all tests and successfully met all acceptance criteria and tests' requirements.
9. Conclusions:
The evaluation of Ditron's modified Dental Implants and Abutments non-clinical tests' results demonstrate that the devices are in-line with their specifications, labeling claims and they have been performed as intended.
It was concluded that the modified devices are as good as the predicate devices and that all performance tests' acceptance criteria were met.
Wherever certain differences exist, these differences were addressed and discussed. Therefore, we believe that the new devices are substantially equivalent to their predicate devices previously cleared.