Ditron's Dental Implants and Abutments are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.

· Two stage: MPI, ULT, API and CPI models

· One stage: OPI and TPI models
The 3.3 and 3.0mm diameter models for One stage OPI and TPI, Two stage and API implants are intended only for the incisors and cuspids of the maxilla and mandible. They are also indicated for denture stabilization using multiple implants.

Two stage and One stage implants for temporary or long-term use: MPI, ULT, API, CPI, OPI and TPI are self-tapping Titanium threaded screws indicated for long term intra bony applications. They permit immediate splint stability and longterm fixation of new or existing crown, bridge and prosthesis and protection of graft sites.

MPI, ULT, API, CPI, OPI and TPI designs are indicated for immediate loading (except for MPI and API in 6.0mm length) when good primary stability is achieved and with appropriate occlusal loading.

MPI, ULT, API, CPI, OPI and TPI are indicated for immediate loading (except for MPI and API in 6.0mm length) in single tooth restorations when good primary stability is achieved with appropriate occlusal loading.

The 30-degree multi-unit abutments must be used within 45 degrees of parallelism for a splinted restoration. The 17-degree multi-unit abutments must be used within 32 degrees of parallelism for a splinted restoration.

Device Description

This submission covers changes related to Ditron's Dental implants and abutments. The inclusion of additional product variations aims to provide dental surgeons with a broader range of implant and abutment options for patient treatment.

The requested additions to Ditron's Dental Implants and Abutments within this 510(k) are hereby described:

. An additional implant type: TPI (Tissue Level (One Piece) Precision Implant) -The TPI design is based on Ditron's cleared MPI Implant model and the 3.0mm Straight Multi-Unit Abutment, creating a one-piece implant. The TPI's implant part is identical to the cleared MPI Implant model, and the 3.0mm MPI Straight Multi-unit part has minor dimensional modifications and color anodization for aesthetic purposes. The TPI compatible Cover and Prosthetic Screws are color anodized as well.

An additional Abutment type: TPI Healing Caps Abutment -● The TPI Healing Caps design is based on Ditron's cleared Cylindered Healing Caps. The TPI Healing Caps are color-anodized for aesthetic purposes. The TPI Healing Caps Abutments are available in several Gingival height dimensions of 3.5, 4.5 and 5.5mm.

. Modification to Cleared Titanium Abutments – Addition of color anodization as an option for all of the Ditron Dental System Titanium Alloy Grade 23 (Ti 6Al-4V ELI) Abutments cleared under K140727 and K161497, to enhance the aesthetic outcome of the dental prosthetics.
An additional Abutment type: TPI Titanium Coping Abutments The TPI ● Titanium Coping Abutment design is based on Ditron's cleared Temporary Abutment. The TPI Titanium Coping Abutments are directly connected to the endosseous dental implant and are intended to provide a basis for prosthetic restoration of single (Crown) or multiple teeth (Bridge). The TPI Titanium Coping Abutment is available in several lengths and restoration options: 11.0mm Bridge, 11.0 Crown, 4.5mm Bridge, 4.5mm Crown.
An additional Abutment type: TPI Overdenture Liberator Abutment The TPI ● Overdenture Liberator Abutment design is based on Ditron's cleared Liberator Abutment. The Liberator Abutment is available in several length dimensions of 2.0, 3.0, 4.0 and 5.0mm.

AI/ML Overview

I am sorry, but the provided text focuses on the substantial equivalence of the "Ditron Dental Implants and Abutments" against predicate devices, primarily discussing changes and additions to the product line and the non-clinical testing performed to support their substantial equivalence for FDA clearance.

The document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria for aspects like:

A table of acceptance criteria and reported device performance: While there's a substantial equivalence table, it compares features and does not list specific acceptance criteria with reported device performance values for a study.
Sample size used for the test set and data provenance: The document mentions non-clinical tests but does not specify sample sizes for test sets (e.g., how many implants were used for fatigue testing, beyond stating "worst case configuration"). It also doesn't discuss data provenance in terms of country of origin or retrospective/prospective for a clinical study.
Number of experts used to establish ground truth and their qualifications: This type of information is relevant for studies involving human interpretation (e.g., image analysis devices), which is not the nature of this submission.
Adjudication method for the test set: Similarly, this is not applicable here as there isn't a "test set" requiring expert adjudication in the context of device performance in a clinical or reader study.
Multi Reader Multi Case (MRMC) comparative effectiveness study and effect size: This type of study is for evaluating human performance with and without AI assistance, which is not applicable to dental implants and abutments.
Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an algorithm.
Type of ground truth used: For physical device testing, ground truth refers to validated measurements or established standards (e.g., ISO standards for fatigue). The document states tests were conducted "with accordance to ISO 14801" for fatigue, but doesn't elaborate further on a "ground truth" as might be understood in AI/clinical studies.
Sample size for the training set: Not applicable as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

The document primarily demonstrates that the new dental implant and abutment variations are substantially equivalent to previously cleared devices based on their identical or similar indications for use, technological characteristics (materials, design, sterilization), and non-clinical performance data (biocompatibility, sterilization validation, surface testing, fatigue testing, shelf life, MRI compatibility). The non-clinical tests performed served to ensure the safety and effectiveness of the new devices align with the predicate devices and established standards.

Therefore, I cannot extract the specific information you requested from the provided text for a "study that proves the device meets the acceptance criteria" in the format you outlined.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Ditron Dental LTD Tali Hazan RA Consultant M.P Upper Galilee Ramot-Naftali, 1383000 ISRAEL

April 30, 2024

Re: K233231

Trade/Device Name: Dental Implants and Abutments Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: March 29, 2024 Received: April 1, 2024

Dear Tali Hazan:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,
Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K233231

Device Name Dental Implants and Abutments

Indications for Use (Describe)

· Two stage: MPI, ULT, API and CPI models

· One stage: OPI and TPI models
The 3.3 and 3.0mm diameter models for One stage OPI and TPI, Two stage and API implants are intended only for the incisors and cuspids of the maxilla and mandible. They are also indicated for denture stabilization using multiple implants.

MPI, ULT, API, CPI, OPI and TPI designs are indicated for immediate loading (except for MPI and API in 6.0mm length) when good primary stability is achieved and with appropriate occlusal loading.

Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the logo for Ditron Dental. The logo consists of a green square with a white triangle cut out of the center on the left side. To the right of the square are the words "DITRON" on top of the word "DENTAL" in a sans-serif font.

510(k) Summary for

Ditron's Dental Implants and Abutments

Date Prepared: April 25, 2024

1. Submitter

Company name:	Ditron Precision Ltd.
Address:	2 Haofe St Ashkelon, 78150 Israel
Phone:	+972-8-6711841
E-mail:	ariel@ditronprecision.com

Contact person:

Name:	Ms. Tali Hazan – RA Consultant
Address:	Ramot Naftali, M.P Upper Galilee, 1383000, Israel
Phone:	+972-(0)50-5292-304
E-mail:	tali.hazan@talmed.co.il

1. Device
  Common or usual name: Dental Implants and Abutments Proprietary/Trade name: Dental Implants and Abutments Implants subtypes: TPI – Tissue Level (One Piece) Precision Implant Classification name: Endosseous Dental Implant (21 CFR 872.3640) Regulatory Class: II Product Code: Primary: DZE, Secondary: NHA

3. Predicate Device

The devices within this submission are substantially equivalent to the following predicate/reference devices:

Primary Predicate Device: Ditron Precision Ltd's legally marketed Dental Implants and . Abutments, cleared under 510(k) number K140728.
Reference Device: Ditron Precision Ltd's legally marketed Dental Implants and Abutments, . cleared under 510(k) number K161497.
. Reference Device: TRI Dental Implants' legally marketed TRI-matrix® Tissue-Level implant, cleared under K203660.

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Image /page/5/Picture/0 description: The image shows the logo for Ditron Dental. The logo consists of a green abstract shape on the left, followed by the words "DITRON" and "DENTAL" stacked on top of each other. The word "DITRON" is on the top line, and the word "DENTAL" is on the bottom line.

Device Description: 4.

The requested additions to Ditron's Dental Implants and Abutments within this 510(k) are hereby described:

. Modification to Cleared Titanium Abutments – Addition of color anodization as an option for all of the Ditron Dental System Titanium Alloy Grade 23 (Ti 6Al-4V ELI) Abutments cleared under K140727 and K161497, to enhance the aesthetic outcome of the dental prosthetics.
An additional Abutment type: TPI Titanium Coping Abutments The TPI Titanium ● Coping Abutment design is based on Ditron's cleared Temporary Abutment. The TPI Titanium Coping Abutments are directly connected to the endosseous dental implant and are intended to provide a basis for prosthetic restoration of single (Crown) or multiple teeth (Bridge). The TPI Titanium Coping Abutment is available in several lengths and restoration options: 11.0mm Bridge, 11.0 Crown, 4.5mm Bridge, 4.5mm Crown.
An additional Abutment type: TPI Overdenture Liberator Abutment The TPI ● Overdenture Liberator Abutment design is based on Ditron's cleared Liberator Abutment. The Liberator Abutment is available in several length dimensions of 2.0, 3.0, 4.0 and 5.0mm.

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Image /page/6/Picture/0 description: The image shows the logo for Ditron Dental. The logo consists of a green letter D on the left and the words "DITRON DENTAL" in black on the right. The letter D is stylized with a white line running through it.

5. Indications for Use:

. Two stage: MPI, ULT, API and CPI models
. One stage: OPI and TPI models

The 3.3 and 3.0mm diameter models for One stage OPI and TPI, Two stage and API implants are intended only for the incisors and cuspids of the maxilla and mandible. They are also indicated for denture stabilization using multiple implants.

Two stage and One stage implants for temporary or long-term use: MPI, ULT, API, CPI, OPI and TPI are self-tapping Titanium threaded screws indicated for long term intra bony applications. They permit immediate splint stability and long-term fixation of new or existing crown, bridge and prosthesis and protection of graft sites.

MPI, ULT, API, CPI, OPI and TPI designs are indicated for immediate loading (except for MPI and API in 6.0mm length) when good primary stability is achieved and with appropriate occlusal loading.

The 30° multi-unit abutments must be used within 45 degrees of parallelism for a splinted restoration.

The 17° multi-unit abutments must be used within 32 degrees of parallelism for a splinted restoration.

Technological Characteristics and Substantial Equivalence: 6.

The subjected devices are substantially equivalent to Ditron's Dental Implants and Abutments that were cleared under K140728 and K161497, and with TRI Dental Implants' TRI-matrix® Tissue-Level implant cleared under K203660, as identified above under the 'predicate devices' section.

The indications for use are identical between the primary predicate and subject device indications for use statement, except for the addition of the TPI model. The additional TPI dental implants and abutments and Ditron's cleared predicate devices have the same indications for use, same shape, design and characteristics. The only characteristics that are not covered by the Ditron cleared predicates is the color anodization of the tissue level part of subject implant and abutments. This characteristic is equivalent to the TRI-matrix® Tissue-Level implant. All of the changes that differentiate the additional TPI dental implants and abutments from the predicate devices were addressed and evaluated.

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Image /page/7/Picture/0 description: The image contains the logo for Ditron Dental. The logo consists of a green square with a white "V" shape inside, followed by the text "DITRON" in black, and "DENTAL" in black below it. The logo is simple and modern, with a focus on the company name.

Table 1: Substantial Equivalence Table - Intended use

- Subject Device -TPI Implant	- Primary Predicate Device -Ditron's Dental Implants andAbutments [MPI, OPI and Multi-UnitAbutment] Cleared under K140728	- Reference Device -Ditron's Dental Implants andAbutments [MPI L6.0mm andLiberator] Cleared under K161497	- Reference Device -TRI Dental Implants'TRI-matrix® ImplantLine [TRI-matrix®Tissue-Level]Cleared underK203660	SubstantialEquivalenceDiscussion
Ditron's Dental Implants and Abutmentsare indicated for use in surgical andrestorative applications for placement inthe bone of the upper or lower jaw toprovide support for prosthetic devices,such as artificial teeth, in order to restorethe patient's chewing function.•Two stage: MPI, ULT, API and CPImodels• One stage: OPI and TPI modelsThe 3.3 and 3.0mm diameter models forOne stage OPI and TPI, Two stage MPI,Two stage and API implants are intendedonly for the incisors and cuspids of themaxilla and mandible. They are alsoindicated for denture stabilization usingmultiple implants.Two stage and One stage implants fortemporary or long-term use: MPI, ULT,API, CPI, OPI, and TPI are self-tappingTitanium threaded screws indicated forlong term intra bony applications. Theypermit immediate splint stability and long-term fixation of new or existing crown,	Ditron's Dental Implants andAbutments are indicated for use insurgical and restorative applicationsfor placement in the bone of theupper or lower jaw to provide supportfor prosthetic devices, such asartificial teeth, in order to restore thepatient's chewing function.• Two stage: MPI, and CPI models• One stage: OPI modelOne stage and One piece OPI 3.3 and3.0 mm diameter implants areintended only for the incisors andcuspids of the maxilla and mandible.They are also indicated for denturestabilization using multiple implants.Two stage and One stage implants fortemporary or long-term use: MPI,CPI, OPI are self-tapping Titaniumthreaded screws indicated for longterm intra bony applications. Theypermit immediate splint stability andlong-term fixation of new or existingcrown, bridge and prosthesis andprotection of graft sites.	Ditron's Dental Implants and Abutments areindicated for use in surgical and restorativeapplications for placement in the bone of theupper or lower jaw to provide support forprosthetic devices, such as artificial teeth, inorder to restore the patient's chewingfunction.• Two stage: MPI, ULT, API and CPImodels• One stage: OPI modelThe 3.3 and 3.0mm diameter models for Onestage OPI, Two stage MPI, Two stage andAPI implants are intended only for theincisors and cuspids of the maxilla andmandible. They are also indicated fordenture stabilization using multipleimplants.Two stage and One stage implants fortemporary or long-term use: MPI, ULT,API, CPI, OPI are self-tapping Titaniumthreaded screws indicated for long term intrabony applications. They permit immediatesplint stability and long-term fixation of newor existing crown, bridge and prosthesis andprotection of graft sites.	The TRI-matrix®Implant Line is intendedfor placement in the boneof the maxillary ormandibular arch for therehabilitation ofedentulous and partiallyedentulous patients.TRI-matrix® ImplantLine allows for one andtwo stage surgicalprocedures. When a onestage surgical procedureis applied, the implantmay be immediatelyloaded when goodprimary stability isachieved and withappropriate occlusalloading. TRI-matrix®Implant Line 6.5 mmimplants are intended fordelayed loading only.The TRI-matrix® Crown	Same.All predicatedevices(primary andreferences),have the sameindications foruse. The MPIlengthdimensionsgreater than6.0mm, multi-unit abutments,and the One-Piece designconcept wereleveraged from510(k) K14072and the 6.0mmlengths of theTPI togetherwith themodifiedLiberator, were
			Abutment is intended for	leveraged from
- Subject Device -TPI Implant	- Primary Predicate Device -Ditron's Dental Implants andAbutments [MPI, OPI and Multi-UnitAbutment] Cleared under K140728	- Reference Device -Ditron's Dental Implants andAbutments [MPI L6.0mm andLiberator] Cleared under K161497	- Reference Device -TRI Dental Implants'TRI-matrix® ImplantLine [TRI-matrix®Tissue-Level]Cleared underK203660	SubstantialEquivalenceDiscussion
bridge and prosthesis and protection of	MPI, CPI, and OPI designs are	MPI, ULT, API, CPI and OPI designs are	use with an endosseous	510(k) K161497
graft sites.	indicated for immediate loading when	indicated for immediate loading (except for	implant to function as a	for the addition
MPI, ULT, API, CPI, OPI and TPI designs	good primary stability is achieved	MPI and API in 6.0mm length) when good	substructure that also	TPI model.
are indicated for immediate loading	and with appropriate occlusal	primary stability is achieved and with	serves as the final	The TRI
(except for MPI and API in 6.0mm length)	loading. MPI, CPI and OPI are	appropriate occlusal loading.	restoration, in a partially	reference device
when good primary stability is achieved	indicated for immediate loading in	MPI, ULT, API, CPI and OPI are indicated	or completely edentulous	includes a
and with appropriate occlusal loading.	single tooth restorations when good	for immediate loading (except for MPI and	patient. The abutment	crown that is not
MPI, ULT, API, CPI, OPI and TPI are	primary stability is achieved with	API in 6.0mm length) in single tooth	screw is intended to	part of the
indicated for immediate loading (except	appropriate occlusal loading.	restorations when good primary stability is	secure the TRI-matrix®	subject device
for MPI and API in 6.0mm length) in	The 30-degree multi-unit abutments	achieved with appropriate occlusal loading.	Crown Abutment to the	and therefore
single tooth restorations when good	must be used within 45 degrees of	The 30-degree multi-unit abutments must be	endosseous implant.	not applicable.
primary stability is achieved with	parallelism for a splinted restoration.	used within 45 degrees of parallelism for a
appropriate occlusal loading.	The 17-degree multi-unit abutments	splinted restoration.
The 30° multi-unit abutments must be used	must be used within 32 degrees of	The 17-degree multi-unit abutments must be
within 45 degrees of parallelism for a	parallelism for a splinted restoration.	used within 32 degrees of parallelism for a
splinted restoration.		splinted restoration.
The 17° multi-unit abutments must be used
within 32 degrees of parallelism for a
splinted restoration.
Feature	- Subject Device -TPI Implant	Primary Predicate DeviceDitron's Dental Implantsand Abutments [MPI,OPI and Multi-UnitAbutment] Clearedunder K140728	Reference Device -Ditron'sDental Implants andAbutments [MPI L6.0mmand Liberator] Cleared underK161497	Reference Device -TRI Dental Implants'TRI-matrix® ImplantLine [TRI-matrix®Tissue-Level]Cleared under K203660	Substantial EquivalenceDiscussion
Material	Ti-6Al-4V-ELI	Ti-6Al-4V-ELI	Ti-6Al-4V-ELI	Ti-6Al-4V-ELI	Identical to all compared devices.
PatientPopulation	Edentulous or partiallyedentulous individuals	Edentulous or partiallyedentulous individuals	Edentulous or partiallyedentulous individuals	Edentulous and partiallyedentulous individuals	Identical to all compared devices.
Placementmethod	Placing the implantimmediately afterdrilling	Placing the implantimmediately after drilling	Placing the implantimmediately after drilling	Placing the implantimmediately after drilling(when a one-stage surgicalprocedure is applied)	Identical to K140728 and K161497.
MaximumAbutmentAngle	0°	MPI: 0° - 30°OPI: 0°	30° for all implants exceptfor: Implants with L=6.0mm:straight abutment only, and;Implants with OD of less than3.75mm: Up to 25°Abutments only.	N/A since the referencedevice is used only for thetissue level surfacetreatment (Coloranodization) comparison.	Similar.All angles are within the clearedrange.
Construction	Machined	Machined	Machined	Machined	Identical to all compared devices.
SurfaceTreatment	• Sand alumina largegrit blasting and Acidetching• Color usinganodization (Blue,Yellow-gold, Pink-Purple and Green) of	• Implants (OPI & MPI):Sand alumina large gritblasting and Acid etching• Multi-Unit: None.	• MPI: Sand alumina large gritblasting and Acid etching.	• Sand alumina large gritblasting and Acidetching.• Color using anodization(Pink-Purple and Green)of the tissue levelimplant neck portion	Similar.The color anodization of the tissuelevel (neck portion) of the implant issimilar to the reference TRI implant.The surface SLA treatment isidentical to K140728 and K161497,except for the anodization colors.
Feature	- Subject Device -TPI Implant	Primary Predicate Device-Ditron's Dental Implantsand Abutments [MPI,OPI and Multi-UnitAbutment] Clearedunder K140728	Reference Device -Ditron'sDental Implants andAbutments [MPI L6.0mmand Liberator] Cleared underK161497	Reference Device -TRI Dental Implants'TRI-matrix® ImplantLine [TRI-matrix®Tissue-Level]Cleared under K203660	Substantial EquivalenceDiscussion
	the tissue level implantneck portion.				to new questions of safety andeffectiveness.
Implant toAbutmentConnection	One-Piece Implant, inwhich the endosseousand abutment portionsconsist of one unit.	OPI: One-Piece implant, inwhich the endosseous andabutment portions consist ofone unit.MPI: Ditron Dental InternalHexagon	Ditron Dental Internal Hexagon	N/A since the referencedevice is used only for thetissue level surfacetreatment comparison	Similar, since Ditron's cleared OPIimplant includes the same one-piececoncept where the implant andabutment are integrated.
ImplantDesign	One-piece design withtapered body (MPIdesign integrated withstraight multi-unitabutment)	• OPI: One-Piece designwith tapered body• MPI: Two-piece modeldesign (implant andabutments including angledmulti-unit abutment), withtapered body	Two-piece MPI model design(short implant and abutmentsincluding straight multi-unitabutment), with Tapered body	N/A since the referencedevice is used only for thetissue level surfacetreatment comparison	Similar.• Ditron's cleared OPI implantincludes the one-piece design withtapered body.• The TPI utilizes the same design asthe MPI when connected to astraight multi-unit, serving as aone-piece implant. Therefore, it isfully covered under the existingdesign of Ditron's implant models.
InterfaceType	Engaging	All: EngagingMulti-Unit only:non-Engaging	Engaging	N/A since the referencedevice is used only for thetissue level surfacetreatment comparison	Identical to all engaging devices inK140728 and K161497.
ProstheticPlatforms	Straight TPI prostheticplatform (Also referredto as "ConnectionPlatform Cone"):external hexalobular	Multi-Unit abutmentplatform (angulated):external hexagon	Multi-Unit abutment platform(Straight): external hexagon	N/A since the referencedevice is used only for thetissue level surfacetreatment comparison	Similar. No new questions of safetyand effectiveness.
Feature	- Subject Device -TPI Implant	Primary Predicate DeviceDitron's Dental Implantsand Abutments [MPI,OPI and Multi-UnitAbutment] Clearedunder K140728	Reference Device -Ditron'sDental Implants andAbutments [MPI L6.0mmand Liberator] Cleared underK161497	Reference Device -TRI Dental Implants'TRI-matrix® ImplantLine TRI-matrix®Tissue-Level]Cleared under K203660	Substantial EquivalenceDiscussion
ImplantDiameter andLengthDimensions(mm)	Ø3.3, Ø3.5 andØ3.75mm for lengths ofL8.0, 10, 11.5, 13 and16mmAnd;Ø4.2 and Ø5.0mm forlengths of: L6.0, 8.0, 10,11.5, 13, 16mm.	MPI: Ø3.5mm, 3.75 mm,4.2 mm, 5.0 mm and 6.0mm for Lengths of: 8.0, 10,11.5, 13 and 16 mm forLengths of: 8.0, 10, 11.5,13and 16mm.OPI: Ø3.0 and 3.3mm forLengths of: L8.0, 10, 11.5.13 and 16mm.	MPI: OD=3.3mm for Lengthsof: L8.0, 10.0, 11.5. 13 and16mm. OD=4.2, 5.0. 6.0 forL=6.0mm.	N/A since the referencedevice is used only forthe tissue level surfacetreatment comparison	Similar. Dimensions fall underexisting range of dimensions.
AbutmentDiameter	TPI Implant Tissue levelelement: Ø4.8mm(refers to the integratedstraight multi-unitabutment portion)	N/A. Since there is nostraight multi-unit abutment.	Ø4.8mm (Straight multi-unitindividual abutment)	N/A since the referencedevice is used only for thetissue level surfacetreatment comparison	Identical to K161497
GingivalHeight(s)	3.0mm	N/A. Since there is nostraight multi-unit abutment.	N/A. Ø1.0, 2.0, 3.0, 4.0, and5.0mm (individual straightmulti-unit abutment)	Gingival Heights, mm1.8 mm	Identical to K161497 sincedimensions fall within the range ofthe cleared straight multi-unit, whichis integrated in the TPI subjectdevice.
Shelf-life	5 Years	5 Years	5 Years	5 Years	Identical to all compared devices.
SterilizationMethod	Gamma Irradiation	Gamma Irradiation	Gamma Irradiation	Gamma Irradiation	Identical to all compared devices.
Single use	Yes	Yes	Yes	Yes	Identical to all compared devices.
Feature	All Subject Abutments	- Primary Predicate Device -Ditron's Dental Implants andAbutments[Multi-Unit Abutment] Clearedunder K140728	- Reference Device -Ditron's Dental Implants andAbutments [Liberator]Cleared under K161497	- Reference Device -TRI Dental Implants' TRI-matrix® Implant Line [TRI-matrix® Tissue-Level, AbutmentScrews]Cleared under K203660	SubstantialEquivalenceDiscussion
Indicationsfor Use	As specified in Table 1 for each device (subject device, predicate device and reference device), since the indications for use statementrefers to both implants and abutments as an integral system.				Identical to allcompared devices.
PatientPopulation	Edentulous or partiallyedentulous individuals	Edentulous or partiallyedentulous individuals	Edentulous or partiallyedentulous individuals	Edentulous and partially edentulousindividuals	Identical to allcompared devices.
Construction	Machined with orwithout anodization	Machined	Machined	Machined with or withoutanodization	Similar to allcompared devices
Material	Ti-6Al-4V-ELI	Ti-6Al-4V-ELI	Ti-6Al-4V-ELI	Ti-6Al-4V-ELI	Identical to allcompared devices.
SurfaceTreatment	Healing Caps,Prosthetic and CoverScrews and optional forall Ditron titaniumabutments: ColorAnodization (Blue,Yellow-gold, Pink-Purple and Green)	Multi-Unit abutment: none	Liberator: None	Implant: Pink anodized collar(Tissue Level)Abutment Screws: Gold anodized	Similar.The anodizationof TRI's referencedevice abutment'stissue level (neckportion) of theimplant and theAbutment Screwsis similar to thesubject device.

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Image /page/8/Picture/0 description: The image contains the logo for Ditron Dental. The logo consists of a green abstract shape resembling a stylized letter "D" on the left, followed by the words "DITRON" and "DENTAL" stacked vertically on the right. The text is in a simple, sans-serif font and is black.

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Image /page/9/Picture/0 description: The image shows the logo for Ditron Dental. The logo consists of a green geometric shape on the left, followed by the words "DITRON" and "DENTAL" stacked on top of each other. The word "DITRON" is on the top line, and the word "DENTAL" is on the bottom line.

Table 2: Table of Substantial Equivalence – Technological Characteristics - TPI Implants

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Image /page/10/Picture/0 description: The image shows the logo for Ditron Dental. The logo consists of a green geometric shape resembling a stylized letter "D" on the left, followed by the words "DITRON" and "DENTAL" stacked vertically on the right. The text is in a simple, sans-serif font and is black.

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Image /page/11/Picture/0 description: The image shows the logo for Ditron Dental. The logo consists of a green geometric shape on the left and the words "DITRON DENTAL" on the right. The word "DITRON" is stacked on top of the word "DENTAL".

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Image /page/12/Picture/0 description: The image shows the logo for Ditron Dental. The logo consists of a green stylized letter D on the left, followed by the words "DITRON" on the top line and "DENTAL" on the bottom line. The text is in a simple, sans-serif font and is black.

Table 3: Table of Substantial Equivalence – Technological Characteristics - Abutments

Note: This part of the substantial equivalence table, summarizes the technological characteristics of the various abutments, and is divided to the mutual aspects relevant to all Ditron's abutments which are applicable to the TPI implant and its associated abutments, followed by each variation, identified and addressed by individually by its own, as follows:

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Image /page/13/Picture/0 description: The image contains the logo for Ditron Dental. The logo consists of a green abstract shape on the left, resembling a stylized letter "D". To the right of the shape, the words "DITRON" and "DENTAL" are stacked vertically, with "DITRON" on top and "DENTAL" below. The text is in a simple, sans-serif font and is black.

Feature	All Subject Abutments	- Primary Predicate Device -Ditron's Dental Implants andAbutments[Multi-Unit Abutment] Clearedunder K140728	- Reference Device -Ditron's Dental Implants andAbutments [Liberator]Cleared under K161497	- Reference Device -TRI Dental Implants' TRI-matrix® Implant Line [TRI-matrix® Tissue-Level, AbutmentScrews]Cleared under K203660	SubstantialEquivalenceDiscussion
SterilizationMethod	Cover Screws:Gamma Irradiation	Cover Screws:Gamma Irradiation	Cover Screws:Gamma Irradiation	Implant:Gamma Irradiation	Identical to allcompared devices
	Other abutments:Non-Sterile Provided	Other abutments:Non-sterile provided	Other abutments:Non-Sterile Provided	Abutment Screws:Non-Sterile Provided
End-UserSterilization	Cover Screws:Sterile Provided	Cover Screws:Sterile Provided	Cover Screws:Sterile Provided	Implants:Sterile Provided	Identical to allcompared devices
	Other abutments:Moist steam sterilization	Other abutments:Moist steam sterilization	Other abutments:Moist steam sterilization	Abutment Screws:Moist steam sterilization
Packaging	Cover Screws:Packaged with implant.	Cover Screws:Packaged with implant.	Cover Screws:Packaged with implant.	N/A since the reference device isused only for the tissue level surfacetreatment comparison	identical toK140728 andK161497
	Other abutments:Prosthetic Pouch	Other abutments:Prosthetic Pouch	Other abutments:Prosthetic Pouch
Single use	Yes	Yes	Yes	Yes	Identical to allcompared devices

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Image /page/14/Picture/0 description: The image shows the logo for Ditron Dental. The logo consists of a green geometric shape on the left, resembling a stylized letter "D" or an abstract tooth. To the right of the shape, the words "DITRON" and "DENTAL" are stacked vertically in a sans-serif font. The overall design is clean and modern, conveying a sense of professionalism and innovation in the dental field.

Table 4: Table of Substantial Equivalence – Technological Characteristics - TPI Healing Cap

Feature	TPI Healing CapSubject Device	MPI Healing CapPredicate Devicecleared underK140728	Substantial Equivalence Discussion
Healing CapDiameter	4.8mm	4.8mm	Identical to K140728
Healing CapHeight	3.5, 4.5, 5.5mm	4.5mm	Similar. The subject device includesadditional height dimensions which do notlead to new questions of safety andeffectiveness.
Duration	180 Days	180 Days	Identical to K140728
Shape	Cylindrical	Cylindrical	Identical to K140728
AbutmentConnection	Straight TPI prosthetic platform:external hexalobular	Ditron Dental Multi-Unit Abutments:external hexagon	Similar.Minor differences in connection platform.This change does not lead to new questionsof safety and effectiveness, since thepredicate device's connection has a similarshape. Yet, the subject device adds a morerobust design due to the additionalhexalobular design (as elaborated inTable 2).

Table 5: Table of Substantial Equivalence – Technological Characteristics - TPI Titanium Copings

Feature	TPI Titanium CopingsAbutment Subject Device	Temporary TitaniumAbutments PredicateDevice cleared underK140728	Substantial Equivalence Discussion
Connection	Coping Abutment Bridges:Non-Engaging.Coping Abutment Crowns:Engaging	Non-Engaging	Similar. No new questions of safety andeffectiveness
Diameter	4.8mm	4.8mm	Identical to K140728
Height	Short Version L4.85mmLong Version L11.0mm	12.0mm	Similar. Slight difference in height that do notlead to new questions of safety andeffectiveness
Shape	Cylindrical with retentiongrooves	Cylindrical withretention grooves	Identical to K140728
AbutmentConnection	Straight TPI prostheticplatform:External hexalobular	Ditron Dental Multi-Unit Abutmentsplatform: ExternalHexagon	Similar. Minor differences in connectionplatform. This change does not lead to newquestions of safety and effectiveness, since thepredicate device's connection has a similar

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Image /page/15/Picture/0 description: The image contains the logo for Ditron Dental. The logo consists of a green abstract shape on the left, resembling a stylized letter D. To the right of the shape are the words "DITRON" stacked on top of "DENTAL" in a simple sans-serif font. The overall design is clean and modern.

Feature	TPI Titanium CopingsAbutment Subject Device	Temporary TitaniumAbutments PredicateDevice cleared underK140728	Substantial Equivalence Discussion
			shape. Yet, the subject device adds a morerobust design due to the additionalhexalobular design (as elaborated in Table 2).
Angulation	0°	0°	Identical to K140728

Table 6: Table of Substantial Equivalence - Technological Characteristics - TPI Liberator Abutments

Feature	TPI Liberator AbutmentsSubject Device	Liberator Abutments ReferenceDevice cleared under K161497	Substantial EquivalenceDiscussion
Height	3.5, 4.5, 5.5mm	2.35, 3.35, 4.35, 5.35, 6.35mm	All dimensions are within therange of the cleared device.
Shape	Cylindrical abutments foroverdentures attachmentsystem	Cylindrical abutments foroverdentures attachment system	Identical to K140728
Surface Treatment	None	None	Identical to K140728
Abutment Connection	Straight TPI prostheticplatform with externalhexalobular	Ditron Dental Straight Multi-Unit Abutments platform:external Hexagon	Minor differences inconnection platform that donot lead to new questions ofsafety and effectiveness
Angulation	0°	0°	Identical to K161497

7. Non-clinical Performance Data:

The following non-clinical tests were performed in order to demonstrate the substantial equivalence of the additional TPI Dental Implants and Abutments:

Biocompatibility: Biocompatibility evaluation and testing according to ISO 10993-1 ● Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity and ISO 10993-11 Biological evaluation of medical devices Part 11: Tests for systemic toxicity together with chemical characterization support the substantial equivalent of the subject device.
Gamma Sterilization Validation: Gamma Sterilization was conducted to all . Ditron sterile provided items with accordance to ISO 11137-2 and AAMI TIR33 (replaced by ISO 13004:2022 with no changes affecting the original sterilization validation) using the VDmax method. All aspects of the Gamma sterilization process and tests remained unchanged as cleared under K140728. The sterilization results supported the SAL of at least 10-6.

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Image /page/16/Picture/0 description: The image shows the logo for Ditron Dental. The logo consists of a green abstract shape resembling the letter 'D' on the left, followed by the words 'DITRON' and 'DENTAL' stacked on top of each other in a sans-serif font. The color of the text is black.

Pyrogen Testing (Bacterial Endotoxin): Pyrogen testing is performed using LAL (Limulus . Amebocyte Lysate) method. The TPI is part of the routine quarterly LAL testing to comply with the testing limit of 20EU per device. The test is performed in accordance with ANSI/AAMI ST72 standard, USP <161> and USP <85>.
Steam Sterilization Validation: Steam Sterilization was conducted to all Ditron abutments that are provided non-sterile and intended to be sterilized by the user at the clinic. The sterilization validation was conducted in accordance to ISO 17665 parts 1 and 2 and; ANSI AAMI ST79 using the overkill / half-cycle method. All aspects of the Steam sterilization validation process and tests remained unchanged as cleared under K140728. The steam sterilization validation results supported the SAL of at least 10-6.
Surface testing: The implants' surface was evaluated by SEM scans and EDS analyses. All ● surface tests results met Ditron's specifications.
Fatigue Testing: There has been no change in the final configuration of the Ditron Dental ● Implants and Abutments system configuration.

Being similar in dimensions to the primary predicate, the TPI provided in straight configuration only and in one-piece design, does not alter the worst-case scenario.

The fatigue tests cleared under K140728 were conducted using worst case configuration and with accordance to ISO 14801 and FDA Guidance document for Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. Since the previously conducted tests cover the additional TPI Implant and abutments, these tests were not repeated.

Implant-Bone Contact Analysis (applicable for short implants with a length of 6.0mm): ● There has been no change in the surface contact, and therefore, these tests were not repeated.
Implant Surface Area Analysis (applicable for short implants in length of 6.0mm): ● There has been no change in the surface area and therefore these tests were not repeated.
Comparative pull-out test (applicable for short implants in length of 6.0mm): The previously . cleared MPI model was tested using a worst-case configuration and therefore no additional testing was conducted.
Shelf life: Shelf life and package integrity along 5 years was validated previously within ● Ditron K140728 cleared products. This test was not repeated since all aspects of packaging and sterile barrier materials, process and process parameters are identical for all Ditron implants (subject devices and cleared devices) as cleared under K140728. ISO 11607-1 standard was followed in order to establish 5 years shelf life and package integrity. All tests met their acceptance criteria.
MRI Compatibility: MRI Compatibility was established based on evaluation against . scientific literature (Woods et al., "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices") and product properties. It was concluded that the device is eligible to bear MR Conditional labeling.

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Image /page/17/Picture/0 description: The image shows the logo for Ditron Dental. The logo consists of a green abstract shape resembling a stylized letter "D" on the left, followed by the words "DITRON" and "DENTAL" stacked vertically on the right. The text is in a simple, sans-serif font and is black in color.

Following the above-described tests and evaluations, it was concluded that the tested devices, whether conducted on the TPI itself or leveraged from Ditron's own discussed predicate devices, passed all tests and successfully met all acceptance criteria and tests' requirements.

8. Substantial Equivalence Conclusion:

The subject TPI dental implants and abutments have the same indications for use,

technological characteristics, mode of operation and performance specifications as the above identified predicate and reference devices. A predicate device for each difference was presented, Similarities and differences were addressed and discussed, and no safety or effectiveness questions were raised.

Based upon the comparison and information described above, Ditron Dental has concluded that its additional TPI dental implants and abutments are substantially equivalent to the discussed primary predicate and reference devices.

Regulation Number and Section

§ 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.