Dental Implants and Abutments

K161497 · Ditron Precision, Ltd. · DZE · Oct 28, 2016 · Dental

Device Facts

• Record ID: K161497
• Device Name: Dental Implants and Abutments
• Applicant: Ditron Precision, Ltd.
• Product Code: DZE · Dental
• Decision Date: Oct 28, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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.

Device Story

Dental implants and abutments; titanium threaded screws; surgically placed in upper/lower jaw bone; provide support for prosthetic devices (crowns, bridges, overdentures). Used by dental surgeons in clinical settings. Features self-tapping design; expanding tapered body; platform-switching configuration; micro-threads. Input: surgical site preparation; Output: stable foundation for prosthetic restoration. Benefits: restoration of chewing function; immediate splint stability; long-term fixation; graft site protection. Abutments include milled, multi-unit, and overdenture retention types. Clinical decision-making supported by primary stability assessment and occlusal loading parameters.

Clinical Evidence

Bench testing only. Biocompatibility (ISO 10993-1), Gamma/Steam sterilization validation (ISO 11137-2, ISO 17665), and fatigue testing (ISO 14801) performed. Fatigue testing used worst-case configurations (smallest diameter, highest angulation). All tests met acceptance criteria.

Technological Characteristics

Material: Ti 6Al-4V-ELI. Design: Conical screw, self-tapping, internal hex connection. Surface: Sand-blasted and acid-etched. Sterilization: Gamma (sterile items) or Steam (non-sterile abutments). Dimensions: Various diameters/lengths. No software/algorithm.

Indications for Use

Indicated for edentulous or partially edentulous patients requiring surgical/restorative dental implants for prosthetic support and restoration of chewing function. Includes temporary or long-term intra-bony use, immediate loading (excluding 6mm MPI/API), and denture stabilization. 3.0/3.3mm diameter models restricted to maxillary/mandibular incisors and cuspids.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Ditron Precision Ltd Dental Implants and Abutments (K140728)
• MIS Implants Technologies Ltd MIS Short Implants (SEVEN) (K103089)
• Implant Direct LLC Legacy3 6mm Length implants (K131097)

Submission Summary (Full Text)

{0}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

PSC Publishing Services [phone] EF

{3}------------------------------------------------

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<br>Ashkelon, 78150<br>Israel |
| Phone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |

## Contact person:

| Name: | Ms. Tali Hazan – RA Consultant |
|----------|----------------------------------|
| Address: | Ramot Naftali, M.P Upper Galilee |
| | 1383000, Israel |
| Phone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |

{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:<br>DZE | DAGRID,<br>Dental |
| | | Secondary:<br>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).

{5}------------------------------------------------

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: [phone] | Fax: [phone]

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<br>and Abutments Predicate<br>Device cleared under<br>K140728 | MIS SEVEN Implants<br>Predicate Device cleared<br>under K103089 | Subject Ditron<br>Dental Implants and<br>Abutments<br>- Subject Device - |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for use | Ditron's Dental Implants and<br>Abutments are indicated for<br>use in surgical and<br>restorative applications for<br>placement in the bone of the<br>upper or lower jaw to<br>provide support for<br>prosthetic devices, such as<br>artificial teeth, in order to<br>restore the patient's chewing<br>function.<br>• Two stage: MPI, and CPI<br>models<br>• One stage: OPI model<br><br>One stage and One piece OPI<br>3.3 and 3.0 mm diameter<br>implants are intended only<br>for the incisors and cuspids<br>of the maxilla and mandible.<br>They are also indicated for<br>denture stabilization using<br>multiple implants.<br><br>Two stage and One stage<br>implants for temporary or<br>long-term use: MPI, CPI,<br>OPI are self-tapping titanium | MIS dental implants are<br>intended to be surgically<br>placed in the bone of the<br>upper or lower jaw arches<br>to provide support for<br>prosthetic devices, such as<br>artificial teeth, in order to<br>restore a patient's chewing<br>function. When a one stage<br>surgical procedure is<br>applied, the implant may be<br>immediately loaded when<br>good primary stability is<br>achieved and the occlusal<br>load is appropriate. MIS<br>short implants are to be<br>used only with straight<br>abutments. | Ditron's Dental Implants and<br>Abutments are indicated for use<br>in surgical and restorative<br>applications for placement in the<br>bone of the upper or lower jaw<br>to provide support for prosthetic<br>devices, such as artificial teeth,<br>in order to restore the patient's<br>chewing function.<br>• Two stage: MPI, ULT, API<br>and CPI models<br>• One stage: OPI model<br><br>The 3.3 and 3.0 mm diameter<br>models for One stage OPI, Two<br>stage MPI, Two stage and API<br>implants are intended only for<br>the incisors and cuspids of the<br>maxilla and mandible. They are<br>also indicated for denture<br>stabilization using multiple<br>implants.<br><br>Two stage and One stage<br>implants for temporary or long-<br>term use: MPI, ULT, API, CPI,<br>OPI are self-tapping titanium |
| Feature | Ditron Dental Implants<br>and Abutments Predicate<br>Device cleared under<br>K140728 | MIS SEVEN Implants<br>Predicate Device cleared<br>under K103089 | Subject Ditron<br>Dental Implants and<br>Abutments<br>- Subject Device - |
| | long term intra bony<br>applications. They permit<br>immediate splint stability and<br>long-term fixation of new or<br>existing crown, bridge and<br>prosthesis and protection of<br>graft sites.<br>MPI, CPI and OPI designs<br>are indicated for immediate<br>loading when good primary<br>stability is achieved and with<br>appropriate occlusal loading.<br>MPI, CPI and OPI are<br>indicated for immediate<br>loading in single tooth<br>restorations when good<br>primary stability is achieved<br>with appropriate occlusal<br>loading.<br>The 30-degree multi-unit<br>abutments shall be used<br>within 45 degrees of<br>parallelism for a splinted<br>restoration. The 17-degree<br>multi-unit abutments shall be<br>used within 32 degrees of<br>parallelism for a splinted<br>restoration. | long term intra bony<br>applications. They permit<br>immediate splint stability and<br>long-term fixation of new or<br>existing crown, bridge and<br>prosthesis and protection of<br>graft sites.<br>MPI, ULT, API, CPI and OPI<br>designs are indicated for<br>immediate loading (except for<br>MPI and API in 6mm length)<br>when good primary stability is<br>achieved and with appropriate<br>occlusal loading.<br>MPI, ULT, API, CPI and OPI<br>are indicated for immediate<br>loading (except for MPI and API<br>in 6mm length) in single tooth<br>restorations when good primary<br>stability is achieved with<br>appropriate occlusal loading.<br>The 30-degree multi-unit<br>abutments shall be used within<br>45 degrees of parallelism for a<br>splinted restoration. The 17-<br>degree multi-unit abutments<br>shall be used within 32 degrees<br>of parallelism for a splinted<br>restoration. | long term intra bony<br>applications. They permit<br>immediate splint stability and<br>long-term fixation of new or<br>existing crown, bridge and<br>prosthesis and protection of<br>graft sites.<br>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<br>Population | Edentulous or partially<br>edentulous individuals | Same population | Edentulous or partially<br>edentulous individuals |
| Implant<br>Models | MPI | MIS Short Implants<br>(SEVEN) | MPI, ULT, API |
| Dimensions<br>of two stage<br>implants | OD= 3.5mm, 3.75 mm, 4.2<br>mm, 5.0 mm for L= 8.0<br>mm, 10 mm, 11.5 mm, 13<br>mm and 16 mm.<br>OD= 6.0 mm for L=8.0<br>mm, 10 mm, 11.5 mm and<br>13 mm. | OD = 4.2, 5.0, 6.0 mm<br>L = 6 mm | MPI<br>OD=3.3 for L=8.0, 10.0,<br>11.5. 13 and 16 mm.<br>OD=4.2, 5.0. 6.0 for L=6mm.<br>ULT<br>OD=3.5, 3.75, 4.2, 5.0, 6.0<br>mm for L = 7.0, 8.0 10.0, |
| Feature | Ditron Dental Implants<br>and Abutments Predicate<br>Device cleared under<br>K140728 | MIS SEVEN Implants<br>Predicate Device cleared<br>under K103089 | Subject Ditron<br>Dental Implants and<br>Abutments<br>- Subject Device - |
| | | | 11.5 13, 16mm<br>API<br>OD=3.3, 3.5 3.75, 4.2, 5.0,<br>6.0mm for L=8, 10,<br>11.5,13.16<br>OD=4.2, 5.0 mm for L=6, 8,<br>10, 11.5,13, 16.<br>OD=6.0 mm for L=6, 8, 10,<br>11.5, 13, 16. |
| Surface | Sand blasting & acid<br>etching | Sand blasting & acid<br>etching | Sand blasting & acid etching |
| Design | Conical screw | Conical screw | Conical screw |
| Sterilization | Sterile: Gamma | Sterile | Sterile: Gamma |
| Placement | Placing the implant<br>immediately after drilling | Same | Placing the implant<br>immediately after drilling |
| method | | | |
| Self-tapping | Yes | Yes | Yes |
| Connection<br>type | Internal hex | Internal Hex | Internal hex |
| Maximum<br>Abutment<br>Angle | 30° | Straight only | 30° for all implants except<br>for: Implants with L=6mm:<br>straight abutment only, and;<br>Implants with OD of less than<br>3.75mm: Up-to 25°<br>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.

www.ditronprecision.com

{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.

www.ditronprecision.com

{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<br>under K140728 | | | | |
|--------------------------------------------------------------------|-----------------------------------------------------------|----------------------------------------------------------------|-------------------------------------------------|---------------------------------------------------------------|
| Ditron P/N | Ditron<br>Abutment<br>Name<br>(*Made of<br>Ti 6Al-4V-ELI) | Ditron Abutment<br>Family Description | Ditron Model<br>Name | Ditron Predicate<br>Device Model<br>*Made of<br>Ti 6Al-4V-ELI |
| ABT-MILL | Anatomic<br>straight<br>abutment with<br>shoulder | Anatomic straight<br>abutment with shoulder<br>6 mm. length | Anatomic straight<br>abutment with<br>shoulder | ABT-6050-2<br>Straight<br>Abutment |
| MUA-10ST | Straight multi-<br>unit Bar retained<br>abutment | Straight multi-unit Bar<br>retained abutment 1.0<br>mm. length | Straight multi-unit<br>Bar retained<br>abutment | BAR-9005<br>Straight multi-<br>unit Bar retained<br>abutment |
| MUA-20ST | Straight multi-<br>unit Bar retained<br>abutment | Straight multi-unit Bar<br>retained abutment 2.0<br>mm length | Straight multi-unit<br>Bar retained<br>abutment | BAR-9015<br>Straight multi-<br>unit Bar retained<br>abutment |
| MUA-30ST | Straight multi-<br>unit Bar retained<br>abutment | Straight multi-unit Bar<br>retained abutment 3.0<br>mm length | Straight multi-unit<br>Bar retained<br>abutment | BAR-9025<br>Straight multi-<br>unit Bar retained<br>abutment |
| MUA-40ST | Straight multi-<br>unit Bar retained<br>abutment | Straight multi-unit Bar<br>retained abutment 4.0<br>mm length | Straight multi-unit<br>Bar retained<br>abutment | BAR-9025<br>Straight multi-<br>unit Bar retained<br>abutment |
| MUA-50ST | Straight multi-<br>unit Bar retained<br>abutment | Straight multi-unit Bar<br>retained abutment 5.0<br>mm length | Straight multi-unit<br>Bar retained<br>abutment | BAR-9025<br>Straight multi-<br>unit Bar retained |
| Subject Abutments compared with Abutments Cleared<br>under K140728 | | | | |
| Ditron P/N | Ditron<br>Abutment<br>Name<br>(*Made of<br>Ti 6Al-4V-ELI) | Ditron Abutment<br>Family Description | Ditron Model<br>Name | Ditron Predicate<br>Device Model<br>*Made of<br>Ti 6Al-4V-ELI |
| LIB-ABT05 | Liberator<br>overdenture<br>retention<br>abutment | Liberator overdenture<br>retention abutment 0.5<br>mm length | Liberator<br>overdenture<br>retention abutment | BAL-10005<br>Ball attachment<br>abutment |
| LIB-ABT10 | Liberator<br>overdenture<br>retention<br>abutment | Liberator overdenture<br>retention abutment 1.0<br>mm length | Liberator<br>overdenture<br>retention abutment | BAL-10005<br>Ball attachment<br>abutment |
| LIB-ABT20 | Liberator<br>overdenture<br>retention<br>abutment | Liberator overdenture<br>retention abutment 2.0<br>mm length | Liberator<br>overdenture<br>retention abutment | BAL-10020<br>Ball attachment<br>abutment |
| LIB-ABT30 | Liberator<br>overdenture<br>retention<br>abutment | Liberator overdenture<br>retention abutment 3.0<br>mm length | Liberator<br>overdenture<br>retention abutment | BAL-10030<br>Ball attachment<br>abutment |
| LIB-ABT40 | Liberator<br>overdenture<br>retention<br>abutment | Liberator overdenture<br>retention abutment 4.0<br>mm length | Liberator<br>overdenture<br>retention abutment | BAL-10040<br>Ball attachment<br>abutment |
| LIB-ABT50 | Liberator<br>overdenture<br>retention<br>abutment | Liberator overdenture<br>retention abutment 5.0<br>mm length | Liberator<br>overdenture<br>retention abutment | BAL-10050<br>Ball attachment<br>abutment |
| Subject Abutments compared with Abutments Cleared<br>under K140728 | | | | |
| Ditron P/N | Ditron<br>Abutment<br>Name<br>(*Made of<br>Ti 6Al-4V-ELI) | Ditron Abutment<br>Family Description | Ditron Model<br>Name | Ditron Predicate<br>Device Model<br>*Made of<br>Ti 6Al-4V-ELI |
| LIB-ABT60 | Liberator<br>overdenture<br>retention<br>abutment | Liberator overdenture<br>retention abutment 6.0<br>mm length | Liberator<br>overdenture<br>retention abutment | BAL-10060<br>Ball attachment<br>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.

www.ditronprecision.com

{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-M…