(207 days)
Not Found
No
The device description and intended use focus solely on the physical components and their mechanical function in dental restoration. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device restores the patient's chewing function by providing support for prosthetic devices (artificial teeth), which is a therapeutic purpose.
No
Explanation: The device, Ditron Dental Implant and Abutments, is described as a surgical and restorative device used for supporting prosthetic devices to restore chewing function. There is no mention of diagnostic capabilities, imaging, or analysis of medical conditions.
No
The device description clearly outlines physical components made of titanium, such as implants, abutments, cover screws, and healing caps. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for surgical and restorative applications within the bone of the jaw to support prosthetic devices and restore chewing function. This is a direct therapeutic and structural application within the body.
- Device Description: The description details the physical components of the dental implant system (implants, abutments, screws, etc.) which are designed to be surgically implanted and provide structural support.
- 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) to provide information for diagnosis, monitoring, or screening.
In summary, the Ditron Dental Implant and Abutments are a medical device used for surgical implantation and structural support, not for in vitro diagnostic testing.
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, CPI models
- One stage: OPI model
One stage and One piece OPI 3.3 and 3.0 mm diameter implants are intended only for the incisors and cuspids of the maxilla and mandible. They are also indicated for denture stabilization using multiple implants.
Two stage and One stage implants for temporary or long-term use: MPI, CPI, OPI are self-tapping titanium threaded screws indicated for long term intra bony applications. They permit immediate splint stability and long-term fixation of new or existing crown, bridge and prosthesis and protection of graft sites.
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 must be used within 45 degrees of parallelism for a splinted restoration. The 17-degree multi-unit abutments must be used within 32 degrees of parallelism for a splinted restoration.
Product codes
DZE, NHA
Device Description
The Ditron Dental Implants and Abutments consist of one and two stage endosseous form dental implants, internal hexagonal implants and external hexagonal abutments, one piece implants system, cover screws and healing caps; abutment systems and superstructures and surgical instruments.
The Molecular Precision Implant (MPI) features an expanding tapered implant body. It is available in lengths of 8.0 mm, 10 mm, 11.5 mm. 13 mm and 16 mm with diameters of 3.5mm, 3.75 mm, 4.2 mm, 5.0 mm and 6.0 mm, except for the 16 mm length which is not available with a diameter of 6.0 mm.
The Cylindrical Precision Implant (CPI) is a cylindrical implant. It is available in lengths of 8.0 mm, 10 mm, 11.5 mm, 13 mm and 16 mm with diameters of 3.75 mm, 4.2 mm, 5.0 mm and 6.0 mm, except for the 16 mm length which is not available with a diameter of 6.0 mm.
The One Piece Implant (OPI) is a one piece implant with an integral abutment designed for one stage procedure and cemented restorations. It is available in lengths of 8, 10, 11.5, 13 and 16 mm with diameters of 3.0 and 3.3 mm Straight Abutments can be used with two platforms; normal and slim. The straight abutments are available at the following lengths of 11.5 and 8.5 mm with a diameter of 4.5 mm, length of 8.5 mm and 6 mm with a diameter of 3.8 mm, length of 2 and 4 mm with a diameter of 5.6 mm.
The Anatomic Angulated Abutment has an anatomic configuration with ascending and descending shoulders the height of the neck varies between 1, 2 and 3mm and is available in 2 different lengths; 1 and 3 mm. These abutments are available with angles of 15° and 25°.
Angulated Abutments are suitable for multi-unit implant restorations and are available with angles of 15° and 25° with lengths of 8.5 mm and 11.5 mm. Ball Retained Abutments feature a titanium ball for overdenture restoration and are available in the following dimensions: 0.5, 2, 3, 4, 5 and 6 mm. Less than 4mm post-height are suitable only for multi-unit loaded restorations.
Temporary Abutments require no cement and are supplied at lengths of 1, 2, 3, 5 and 7 mm.
Bar Retained Abutments less than 4mm post-height are suitable only for multiunit loaded restorations and are supplied in the following dimensions: 0.5, 1.5, 2.5 mm.
Multi-Unit Bar Retained Abutments provides support and retention for mutiunit screw-retained restorations and are available in two heights: 0.5mm and 1mm, and; two angles: 17° and 30° for each height for multi-unit loaded restorations.
Screw Retained Abutment is a supporting structure used to support lateral or horizontal pressure as an anchorage for single tooth or more (bridge). The package is supplied with the abutment and the matching screw. Less than 4mm post-height are suitable only for multi-unit loaded restorations or for single-unit loaded restorations if used in combination with plastic sleeve per Ditron labeling. Cover screw is made of titanium and supplied sterile with the implant.
All implants and body contact abutments are made of biocompatible Titanium 6A1-4V-ELI.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
A series of safety and performance tests and evaluations were performed to demonstrate that Ditron's Dental Implant System does not raise any new issues of safety and effectiveness. These evaluations include fatigue, surface analysis, biocompatibility, sterilization validation and shelf life validation in order to assure maintaining of SAL 10to along the shelf life.
All results are supporting Ditron's labeling claims in order to establish substantial equivalency.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a family of three people in profile, representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 17, 2014
Ditron Precision, Limited C/O Ms. Tali Hazan Regulatory Consultant Ramot-Naftali M.P Upper Galilee, 13830 ISRAEL
Re: K140728
Trade/Device Name: Dental Implants and Abutments Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE, NHA Dated: September 21, 2014 Received: September 25, 2014
Dear Ms. 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.
1
Page 2 - Ms. Hazan
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Susan Runno, DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known): K140728
Device Name: Dental Implants and Abutments
*Models names identification:
- · MPI Molecular Precision Implant
- · CPI Cylindrical Precision Implant
- · OPI One Piece Implant
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, 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 selftapping 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, 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 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.
ر Prescription Use __ كا (Part 21 CFR 801 Subpart D)
4-1
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
3
Ditron Precision Ltd, P.O.B. 5010, Ashkelon 78150, I: 2 Haofe St. Southern Ind. Zone, Ashkelon 78780, Isra Tel: +972-8-6711841 | Fax: +972-8-67
Image /page/3/Picture/1 description: The image shows two logos for companies named Ditron. The top logo is for Ditron Precision and features the word "DITRON" in bold, black letters, with the word "PRECISION" in smaller, red letters underneath. To the left of the word "DITRON" is a red, angular shape. The bottom logo is for Ditron Dental and features the word "DITRON" in a similar font to the top logo, with the word "DENTAL" underneath. To the left of the word "DITRON" is a green, angular shape.
דיטרון תעשיות רע״מ. ת.ד. 5010 רח' האופה 2. אזור התעשיה
Image /page/3/Picture/3 description: The image contains two lines of text and a logo. The first line of text is "ditronprecision.com" in black. The second line of text is "www.ditrondental.com" in blue. To the right of the text is a logo with the letters "nqa" and the text "TS 16949 Registered".
510(k) Summary for Ditron's Dental Implants and Abutments
1. Date Prepared: 15 March 2014
2. 510(k) Owner Name:
Ditron Precision Ltd. Haofe 2St. Ashkelon, 78150, Israel Phone: +972-8-6711841, Fax: +972-9-6711843, Email: orlev@ditronprecision.com
Contact person:
Ms. Tali Hazan - RA Consultant Phone: +972-(0)50-5292-304 Fax: +972-(0)722448981 Email: tali.hazan@talmed.co.il
3. Device Name and Classification:
Common/Usual Name: Dental Implants and Abutments Proprietary/Trade name(s): MPI - Molecular Precision Implant): CPI - Cylindrical Precision Implant), and; OPI – One Piece Implant. Classification: Ditron Dental Implants and Abutments have been classified as
Class II devices under the following classification names:
| Regulation Description | Product Code | 21 CFR Ref. | Panel |
|---|---|---|---|
| Endosseous dental implant | Primary: DZE | ||
| Secondary: NHA | 872.3640 | DAGRID, | |
| Dental |
4
Ditron Precision Ltd, P.O.B. 5010, Ashkelon 78150, 2 Haofe St. Southern Ind. Zone, Ashkelon 78780, I Tel: +972-8-6711841 | Fax: +972-8-6
Image /page/4/Picture/1 description: The image shows two logos. The top logo is for "DITRON PRECISION" with the word "DITRON" in bold black letters and the word "PRECISION" in smaller black letters below it. To the left of the word "DITRON" is a red symbol that looks like a stylized letter "C". The bottom logo is for "DITRON DENTAL" with the word "DITRON" in light gray letters and the word "DENTAL" in bold black letters below it. To the left of the word "DITRON" is a green symbol that looks like a stylized letter "E".
דיטרון תעשיות בע"מ. ת.ד. 5010. אשקל רח' האופה 2. אזור התעשיה הד
4. Predicate Devices:
Ditron's Dental Implants and Abutments are substantially equivalent to the following Predicate Devices:
- 4.1 Alpha-Bio Tec® Dental Implant System (by Alpha-Bio Tec Ltd) cleared under K063364; product code DZE (Implant, Endosseous, Root-Form).
- 4.2 AB Dental Abutments (by AB Dental Ltd) cleared under K112440; product code NHA Endosseous Dental Implant Abutment.
- 4.3 Prismatik Dentalcraft Multi-Unit Abutments with Angulations 17° and 30° for Tapered Implant System (by Prismatik Dentalcraft Inc) cleared under K121688; product code NHA Endosseous dental implant.
5. Intended Use/Indications for Use:
The Ditron Dental Implant 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, CPI
- · One stage: OPI
One stage and One piece OPI 3.3 and 3.0 mm diameter implants are intended only for the incisors and cuspids of the maxilla and mandible. They are also indicated for denture stabilization using multiple implants.
Two stage and One stage implants for temporary or long-term use: MPI, CPI, OPI are self-tapping titanium threaded screws indicated for long term intra bony applications. They permit immediate splint stability and long-term fixation of new or existing crown, bridge and prosthesis and protection of graft sites. 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 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.
5
Ditron Precision Ltd, P.O.B. 5010, Ashkelon 78150, Israe 2 Haofe St. Southern Ind. Zone, Ashkelon 78780, Israel Tel: +972-8-6711841 | Fax: +972-8-6711843
Image /page/5/Picture/1 description: The image shows two logos for companies named Ditron. The top logo is for Ditron Precision and features the word "DITRON" in bold, black letters, with the word "PRECISION" in smaller, black letters underneath. To the left of the word "DITRON" is a red, geometric shape that resembles an arrow pointing to the left. The bottom logo is for Ditron Dental and features the word "DITRON" in gray letters, with the word "DENTAL" in smaller, gray letters underneath. To the left of the word "DITRON" is a green, geometric shape that resembles a stylized letter "D".
דיטרון תעשיות בע״מ, ת.ד. 5010, אשקלון 8150 רח' האופה 2, אזור התעשיה הדרומי, אשקלון טל. 08-6711841 | פקס. 08-6711841
6. Device Description:
The Ditron Dental Implants and Abutments consist of one and two stage endosseous form dental implants, internal hexagonal implants and external hexagonal abutments, one piece implants system, cover screws and healing caps; abutment systems and superstructures and surgical instruments.
The Molecular Precision Implant (MPI) features an expanding tapered implant body. It is available in lengths of 8.0 mm, 10 mm, 11.5 mm. 13 mm and 16 mm with diameters of 3.5mm, 3.75 mm, 4.2 mm, 5.0 mm and 6.0 mm, except for the 16 mm length which is not available with a diameter of 6.0 mm.
The Cylindrical Precision Implant (CPI) is a cylindrical implant. It is available in lengths of 8.0 mm, 10 mm, 11.5 mm, 13 mm and 16 mm with diameters of 3.75 mm, 4.2 mm, 5.0 mm and 6.0 mm, except for the 16 mm length which is not available with a diameter of 6.0 mm.
The One Piece Implant (OPI) is a one piece implant with an integral abutment designed for one stage procedure and cemented restorations. It is available in lengths of 8, 10, 11.5, 13 and 16 mm with diameters of 3.0 and 3.3 mm Straight Abutments can be used with two platforms; normal and slim. The straight abutments are available at the following lengths of 11.5 and 8.5 mm with a diameter of 4.5 mm, length of 8.5 mm and 6 mm with a diameter of 3.8 mm, length of 2 and 4 mm with a diameter of 5.6 mm.
The Anatomic Angulated Abutment has an anatomic configuration with ascending and descending shoulders the height of the neck varies between 1, 2 and 3mm and is available in 2 different lengths; 1 and 3 mm. These abutments are available with angles of 15° and 25°.
Angulated Abutments are suitable for multi-unit implant restorations and are available with angles of 15° and 25° with lengths of 8.5 mm and 11.5 mm. Ball Retained Abutments feature a titanium ball for overdenture restoration and
are available in the following dimensions: 0.5, 2, 3, 4, 5 and 6 mm. Less than 4mm post-height are suitable only for multi-unit loaded restorations.
Temporary Abutments require no cement and are supplied at lengths of 1, 2, 3, 5 and 7 mm.
Bar Retained Abutments less than 4mm post-height are suitable only for multiunit loaded restorations and are supplied in the following dimensions: 0.5, 1.5, 2.5 mm.
Multi-Unit Bar Retained Abutments provides support and retention for mutiunit screw-retained restorations and are available in two heights: 0.5mm and 1mm, and; two angles: 17° and 30° for each height for multi-unit loaded restorations.
6
Image /page/6/Picture/1 description: The image contains two logos for companies named "Ditron". The top logo, "Ditron Precision", features the word "DITRON" in bold, black letters, with the word "PRECISION" in smaller, black letters to the right. To the left of "DITRON" is a red, angular shape. The bottom logo, "Ditron Dental", has the word "DITRON" in gray letters above the word "DENTAL" in larger, gray letters. To the left of "DITRON" is a green shape that resembles a stylized "D".
דיטרון תעשיות רע"מ. ת.ד. 5010. אשקלו רח' האופה 2. אזור התעשיה הדרומי
Screw Retained Abutment is a supporting structure used to support lateral or horizontal pressure as an anchorage for single tooth or more (bridge). The package is supplied with the abutment and the matching screw. Less than 4mm post-height are suitable only for multi-unit loaded restorations or for single-unit loaded restorations if used in combination with plastic sleeve per Ditron labeling. Cover screw is made of titanium and supplied sterile with the implant.
All implants and body contact abutments are made of biocompatible Titanium 6A1-4V-ELI.
7. Substantial Equivalence:
The proposed Ditron Dental Implants and Abutments have similar indications for use, technological characteristics, mode of operation and, performance specification as the above identified predicate devices. The proposed device utilizes same intended use as the predicates and is placed using the same methodology as all of the selected predicate devices. Both the proposed and predicate devices function in the same manner providing support for prosthetic devices in the upper or lower jaw.
8. Performance Testing:
A series of safety and performance tests and evaluations were performed to demonstrate that Ditron's Dental Implant System does not raise any new issues of safety and effectiveness. These evaluations include fatigue, surface analysis, biocompatibility, sterilization validation and shelf life validation in order to assure maintaining of SAL 10to along the shelf life.
All results are supporting Ditron's labeling claims in order to establish substantial equivalency.
9. Summary and Conclusion:
We believe that Ditron Dental Implants and Abutments, which are the subject of this 510(k) submission, are substantially equivalent to the predicate devices cited above. The device constitutes a safe, reliable and effective medical device, meeting all declared requirements of its intended use and the device does not introduce new risks and does not present any new adverse health effects or safety potential risks to patients when used as intended.