(89 days)
TRATE Dental Implant System is 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. TRATE Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The TRATE Dental Implant System is an endosseous dental implant and abutment system consisting of screw-type implants manufactured of Titanium Alloy (Ti6AIV4. acc. to EN ISO 5832-3/ASTM F136). The implants are blasted with HAP / TCP for surface roughening, acid-etched and anodized. The cover screws, abutment fixation screws and abutments are made of Titanium Alloy (Ti6A14V). Some subject devices are surfaced anodized. TRATE Dental Implants are two-piece implants: TRATE Dental Implant System implant type is a two-component ROOTFORM implant with combined thread and tapered connection is intended for surgical placement in the upper or lower jaw to support crowns, bridges or overdentures in edentulous and partially edentulous jaws of patients in order to restore the patients chewing for single or multiple unit restorations. TRATE Dental Implant System implants are indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Here's a breakdown of the acceptance criteria and study information for the TRATE Dental Implant System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices like dental implants, "acceptance criteria" usually refer to performance specifications that the device must meet, often demonstrated through specific tests. The document mainly outlines a series of non-clinical tests rather than a statistical performance metric against clinical criteria.
| Acceptance Criteria (Test/Standard) | Reported Device Performance / Evaluation Method |
|---|---|
| Biocompatibility (ISO 10993) | Testing conducted to evaluate biocompatibility. (Implied: Meets ISO 10993 standards). |
| Bacterial Endotoxin Levels (ANSI/AAMI ST72) | Batch testing conducted on samples of water used in manufacturing (bimonthly) and from sterilized product (quarterly) to demonstrate levels < 20 EU/device. |
| Sterility Levels (ISO 11137-1, -2 for implants; ISO 17665-1, -2 for abutments) | Implant sterilization validation conducted according to ISO 11137-1, -2. Abutment sterilization conducted according to ISO 17665-1, -2. (Implied: Meets standards). |
| Total Organic Content | Testing conducted. (Implied: Meets acceptable levels). |
| Dynamic Compression-Bending Fatigue (ISO 14801) | Dynamic fatigue testing performed on worst-case subject device constructs. Additional collar lengths for abutments were addressed through bench testing (ISO 14801). (Implied: Demonstrated acceptable mechanical performance and similar maximum loads to predicate devices). |
| Surface Analysis (SEM & EDX) | Surface evaluation performed. (Implied: Confirmed the blasted, acid-etched, and anodized surface treatment). |
| Package Integrity and Accelerated Aging (ISO 11607) | Testing conducted. (Implied: Demonstrates package maintains integrity and sterility over time). Differences in sterile barrier packaging were addressed via labeling mitigations. |
| MR Compatibility (FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque) | Non-clinical worst-case MRI review performed using scientific rationale and published literature (e.g., Woods, Terry O., et al. 2019) to evaluate the entire system (all compatible implant bodies, dental abutments, and fixation screws). Reported: MR Conditional. |
2. Sample Size Used for the Test Set and Data Provenance
- The document does not specify a separate "test set" in the context of clinical performance or a distinct dataset for algorithm validation. The evaluations performed are non-clinical bench and lab tests.
- For the non-clinical tests (biocompatibility, endotoxin, sterility, mechanical fatigue, etc.), specific sample sizes for each test are not provided in this summary.
- The data provenance is non-clinical bench testing and scientific rationale, implying laboratory-controlled environments rather than patient data from a specific country or retrospective/prospective study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This information is not applicable as the evaluation is based on non-clinical testing and comparison to predicate devices, not human expert assessment of clinical data.
4. Adjudication Method
- This information is not applicable as there is no clinical data or expert review process described that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in this document. The submission focuses on substantial equivalence through non-clinical testing and technological comparison.
6. Standalone Performance Study
- Yes, a form of "standalone" performance was done in the sense of the device itself undergoing various non-clinical performance and safety tests (e.g., mechanical fatigue, sterility, biocompatibility). However, this is not a standalone algorithm-only performance evaluation, as this is a physical medical device, not an AI/software device.
7. Type of Ground Truth Used
- The "ground truth" for the non-clinical tests is established by conformance to recognized international standards and methodologies (e.g., ISO 14801 for fatigue testing, ISO 10993 for biocompatibility, ISO 11137 for sterility) and scientific rationale. For substantial equivalence, the "ground truth" is largely the performance and characteristics of the legally marketed predicate devices.
8. Sample Size for the Training Set
- This information is not applicable as this is a physical medical device and not an AI/machine learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable for the same reason as point 8.
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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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Trate AG % Jorge Millan Regulatory Director Sigma Biomedical 7737 N University Drive, Suite 101 Tamarac, Florida 33321
Re: K220022
Trade/Device Name: TRATE Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: December 21, 2021 Received: January 5, 2022
Dear Jorge Millan:
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. 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 located 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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lence determination does not mean that FDA
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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 Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220022
Device Name TRATE DENTAL IMPLANT SYSTEM
Indications for Use (Describe)
TRATE Dental Implant System is 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. TRATE Dental Implant System is indicated also for immediate loading 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/3/Picture/0 description: The image shows the logo for TRATE Dental Implant System. The word "TRATE" is in large, red, bold letters. To the right of "TRATE" are the words "Dental Implant System" in a smaller, black, bold font.
510(K) Summary
Submitter Information
| Submitter | TRATE AGSeestrasse 58H-8806 Bäch (Switzerland)Phone: +41 44 202 1919Fax:+41 44 202 1920 |
|---|---|
| Contact: | Jorge Millan, PhD |
| Telephone number | (786) 416-5587 |
| Fax number | (305) 328-4511 |
| sigmabiomedical@gmail.com | |
| Date prepared: | April 4, 2022 |
Subject Device Name
| Trade/Proprietary Name: | TRATE Dental Implant System |
|---|---|
| Common or Usual Name: | Root-form Endosseous Dental Implants & Abutments |
| Regulation Number: | 21 CFR 872.3640 |
| Regulation Name: | Endosseous dental implants |
| Product Code: | DZE (Primary)NHA (Additional) |
| Class | II |
| Panel | Dental |
Predicate Devices
| Predicate Devices: | Primary Predicate:A.B. Dental Devices Ltd., K162482 |
|---|---|
| Reference devices:A.B. Dental Devices Ltd., K132125 |
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Image /page/4/Picture/0 description: The image shows the logo for TRATE Dental Implant System. The word "TRATE" is in large, red, bold letters. To the right of "TRATE" are the words "Dental Implant System" in a smaller, black, bold font. The logo is simple and professional.
Device Description:
The TRATE Dental Implant System is an endosseous dental implant and abutment system consisting of screw-type implants manufactured of Titanium Alloy (Ti6AIV4. acc. to EN ISO 5832-3/ASTM F136). The implants are blasted with HAP / TCP for surface roughening, acid-etched and anodized. The cover screws, abutment fixation screws and abutments are made of Titanium Alloy (Ti6A14V). Some subject devices are surfaced anodized. TRATE Dental Implants are two-piece implants:
TRATE Dental Implant System implant type is a two-component ROOTFORM implant with combined thread and tapered connection is intended for surgical placement in the upper or lower jaw to support crowns, bridges or overdentures in edentulous and partially edentulous jaws of patients in order to restore the patients chewing for single or multiple unit restorations. TRATE Dental Implant System implants are indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Implant model:
ROOTFORM Dental Implant Diameters: 3.5 mm, 3.8 mm, 4.2 mm, 4.8 mm, 5.5 mm For each diameter, available lengths: 8 mm, 10 mm, 12 mm, 16 mm, 16 mm
Abutment models:
| Type of abutment | Diameter | Lengths |
|---|---|---|
| Gingiva formers (GFx, GFNx) | 4 mm, 5 mm | 0.5 mm - 7 mm |
| Anatomical straight (Ax, A1N) | 3.98 mm, 4.8 mm | 9.3 mm, 10.3 mm, 11.3 mm, 12.3 mm |
| Anatomical angled 15°, 25° (AxAxx) | 4.8 mm, 4.9 mm | 9 mm, 10 mm, 11 mm, 12 mm |
| Multi-unit straight (Mx, MSx) | 4 mm, 4.5 mm | 1 mm, 2 mm, 3 mm, 4 mm |
| Multi-unit angled 15° (MxAxx) | 4 mm | 1 mm, 2 mm, 3 mm, 4 mm |
| Cover screws/Abutment fixation screws | One size only | One size only |
Temporary Abutments
A gingiva former, called else as a healing cap or healing abutment that is screwed onto the top of the implant. Healing abutment placement is based on the surgical technique followed i.e., immediately placed during single stage surgical procedure or later at two-stage surgical protocol to guide the healing of soft tissue to replicate the contours and dimensions of natural tooth that is being replaced and to ensure access to the implant restorative platforms for impression and definitive abutment placement. In TRATE Dental Implant System available a few variations of gingiva formers: Regular gingiva formers and narrow gingiva formers.
Retained Abutments
An abutment is a component that is intermediate between the restoration and is retained to the implant by a screw. In TRATE system available are the following variations of abutments: Anatomical straight abutments (regular and narrow), anatomical angled abutments, multi-unit straight abutments (regular and narrow), multi-unit angled abutments.
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Image /page/5/Picture/0 description: The image contains the logo for "TRATE Dental Implant System". The word "TRATE" is in large, bold, red letters. To the right of "TRATE" are the words "Dental Implant System" in a smaller, black, serif font.
Indications for Use:
TRATE Dental Implant System is 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. TRATE Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Non-Clinical Data:
In support of substantial equivalence safety and performance testing has been conducted to evaluate biocompatibility, bacterial endotoxin levels, sterility levels, total organic content. Mechanical performance in terms of dynamic compression-bending testing was performed to support substantial equivalence. Dynamic testing was performed on worst-case subject device constructs. Non-clinical product evaluation to demonstrate substantial equivalence includes:
- Dynamic fatigue testing according to ISO 14801
- Biocompatibility testing according to ISO 10993 ●
- Surface analysis SEM & EDX-surface evaluation
- Bacterial endotoxin batch testing including Limulus amebocyte lysate (LAL) test will be . conducted according to ANSI/AAMI ST72 on samples of water used in manufacturing on a bimonthly basis and on samples from sterilized product on a quarterly basis to demonstrate all sterile product meets a limit of< 20 EU/device.
- Implant sterilization validation was conducted on the implants according to ISO 11137-1, -2 ●
- Abutment sterilization vas conducted on the implants according to ISO 17665-1, -2
- Package integrity testing and accelerated aging were conducted according to ISO 11607
- Non-clinical worst-case MRI review was performed to evaluate the metallic TRATE Dental ● Implant System devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
| Device | TRATE Dental Implant System | A.B. Dental DevicesDental Implant System | A.B. Dental DevicesDental Implant System(Reference Device) |
|---|---|---|---|
| 510K | K220022 | K162482 | K132125 |
| RegulationDescription | Endosseous Dental Implant | Endosseous Dental Implant | Endosseous Dental Implant |
| Class | Class II | Class II | Class II |
| Product Code | DZE | DZE | DZE |
| Regulation Number | 872.3640 | 872.3640 | 872.3640 |
Technological Characteristics Comparison
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Image /page/6/Picture/0 description: The image shows the logo for TRATE Dental Implant System. The word "TRATE" is in large, bold, red letters. To the right of the word "TRATE" are the words "Dental Implant System" in a smaller, black, bold font.
K220022
| Indications for Use | TRATE Dental Implant System isindicated for use in surgical andrestorative applications forplacement in the bone of the upperor lower jaw to provide support forprosthetic devices, such asartificial teeth, in order to restorethe patient's chewing function.TRATE Dental Implant System isindicated also for immediateloading when good primarystability is achieved and withappropriate occlusal loading. | A.B. Dental Devices -DentalImplant System is indicated foruse in surgical and restorativeapplications for placement in thebone of the upper and lower jaw toprovide support for prostheticdevices, such as artificial teeth, inorder to restore the patient'schewing function.A.B.Dental Devices DentalImplant System is indicated alsofor immediate loading when goodprimary stability is achieved andwith appropriate occlusal loading.P4 and P14 abutments are to be usedonly with standard platform implants3.5 mm diameter or larger | A.B. DENTAL DEVICES@Dental Implants System isindicated for use in surgical andrestorative applications forplacement in the bone of the upperor lower jaw to provide supportfor prosthetic devices, such asartificial teeth, in order to restorethe patient's chewing function.A.B. DENTAL DEVICES@Dental Implants System isindicated also for immediateloading when good primarystability is achieved and withappropriate occlusal loading. |
|---|---|---|---|
| Surgical ProcedureType | Single-Stage | Single-Stage | Single-Stage |
| Two-Stage procedures | Two-Stage procedures | Two-Stage procedures |
| Implants | ||
|---|---|---|
| 510K | K220022 | K162482 |
| Raw Material | Ti6Al4V | Ti6Al4V |
| SurfaceTreatment | Blasted and acid etched | Blasted and acid etched |
| Implant /Abutmentconnection | Internal hex | Internal hex |
| Implant Bodycontour | Tapered and conical | Tapered and conical |
| Self-taping | Yes | Yes |
| Sterilizationmethod | Gamma | Gamma |
| Packaging(MicrobialBarrier) | Single sterile barrier (Tyvek-lidded blister) | Double Sterile barrier (Plastic container with a ca) |
| Diameters | Diameter: 3.5 mm, 3.8 mm, 4.2 mm, 4.8 mm, 5.5 mm | Diameter: 3.5 mm, 3.75 mm, 4.2 mm, 4.5 mm, 5 mm, 6 mm |
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ental Implant System
K220022
| Lengths | Length: 8 mm, 10 mm, 12 mm, 14 mm, 16 mm foreach of the implant diameters | Lengths: 8 mm, 10 mm, 11.5 mm, 13 mm, 16 mm foreach of the implant diameters |
|---|---|---|
| MRICompatibility | MR Conditional | Unknown |
TRATE implants are similar to the predicate implants with insignificant difference in:
- diameter. The wide diameter implants have more material than a standard diameter abutment. Therefore, TRATE Implants does not create a new, worst case.
- -Material, manufacturing methods (including color anodization) and sterility are substantially equivalent between the subject and predicate device
- -MR Conditional labeling was established by evaluating the system (including worst-case(s) of all variations of compatible implant bodies, dental abutments, and fixation screws) based on scientific rationale and published literature.
- Differences in sterile barrier packaging are addressed via labeling mitigations to ensure sterility is maintained during unpackaging.
| Description | Healing Caps (GFx, GFNx) | Healing Caps (P0) |
|---|---|---|
| 510K | K220022 | K132125 |
| Raw Material | Ti6Al4V | Ti6Al4V |
| Microbial state /Sterilization method | Non-sterile / steam | Non-sterile / steam |
| Platform | Narrow, Standard | Narrow, Standard |
| Diameter | 4 mm, 5 mm | 4 mm, 4.5 mm |
| Collar Length | 0.5 mm - 7 mm | 0.5 mm - 7 mm |
| Angle | No | No |
| Sterility | Non-sterile | Non-sterile |
TRATE abutments are similar to the predicate abutments with insignificant difference in:
diameter. The wide diameter abutment has more material than a standard diameter abutment. Therefore, this abutment does not create a new, worst case.
Material, manufacturing methods (including color anodization) and sterility are substantial equivalent between the subject and predicate device
| Description | Abutments anatomic straight (Ax, A1N) | Abutments straight (P3) |
|---|---|---|
| 510K | K220022 | K132125 |
| Raw Material | Ti6Al4V | Ti6Al4V |
| Microbial state /Sterilization method | Non-sterile / steam | Non-sterile / steam |
| Collar length (mm) | 1 mm, 2 mm, 3 mm, 4 mm | 1 mm, 2 mm, 3 mm |
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Dental Implant System
K220022
| Platform | Narrow, Standard | Narrow, Standard |
|---|---|---|
| Diameter | 3.98 mm, 4.8 mm | 3.75 mm, 4.5 mm, 5 mm, 5.5 mm |
| Length | 9.3 mm, 10.3 mm, 11.3 mm, 12.3 mm | 5 mm, 7 mm, 9 mm, 11 mm, 12 mm, 15 mm |
| Angle | No | No |
| Cement Retained | Yes | Yes |
| Sterility | Non-sterile | Non-sterile |
TRATE abutments are similar to the predicate abutments with insignificant difference in:
diameter. The subject device abutment has a bigger smallest diameter than a predicate abutment does not create a new, worst case.
collar length. The addition of an additional collar length does not create a new worst-case for straight abutments -
length. Length of subject device in between the range of predicate device and this is not create a new worst-case
-Material, manufacturing methods (including color anodization) and sterility are substantial equivalent between the subject and predicate device
| Description | Abutments anatomic angled (AxAxx) | Abutments anatomic angled (P4) |
|---|---|---|
| 510K | K220022 | K162482 |
| Raw Material | Ti6Al4V | Ti6Al4V |
| Microbial state /Sterilization method | Non-sterile / steam | Non-sterile / steam |
| Collar length (mm) | 1 mm, 2 mm, 3 mm, 4 mm | 1 mm, 2 mm, 3 mm |
| Platform | Standard | Narrow, Standard |
| Diameter | 4.8 mm, 4.9 mm | 4,7 mm, 5 mmm |
| Length | 9 mm, 10 mm, 11 mm, 12 mm | 9 mm, 10 mm, 10.75 mm, 11 mm, 12 mm |
| Angle | 15°, 25° | 15°, 25° |
| Cement Retained | Yes | Yes |
| Sterility | Non-sterile | Non-sterile |
TRATE abutments are similar to the predicate abutments with insignificant difference in:
collar length. Adding longer collar length is addressed through bench testing (ISO 14801). Thus, established compatibility limitations to the angled abutments (MxAxx abutments are to be used only with implants 3.5 mm diameter or larger and only for multiple unit restorations).
diameter. because predicate device have smaller diameter, subject devices does not create a new worst-case
-Material, manufacturing methods (including color anodization), and sterility are substantial equivalent between the subject and predicate device
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Image /page/9/Picture/0 description: The image contains the words "TRATE Dental Implant System". The word "TRATE" is in large red font. The words "Dental Implant System" are in a smaller black font and are to the right of the word "TRATE".
| Description | Multi-unit abutments straight (Mx, MSx) | Straight adaptor (P16) |
|---|---|---|
| 510K | K220022 | K132125 |
| Raw Material | Ti6Al4V | Ti6Al4V |
| Microbial state /Sterilization method | Non-sterile / steam | Non-sterile / steam |
| Collar length (mm) | 1 mm, 2 mm, 3 mm, 4 mm | 1 mm, 2 mm, 3 mm, 4 mm, 5 mm |
| Platform | Narrow, Standard | Narrow, Standard |
| Diameter | 4 mm, 4.5 mm | 4 mm, 4.5 mm |
| Angle | No | No |
| Cement Retained | Yes | Yes |
| Sterility | Non-sterile | Non-sterile |
The two abutments have the same design, and differ only in one additional length available in the subject predicate. Material, manufacturing methods, and sterility are substantial equivalent between the subject and predicate device
| Description | Multi-unit abutments angled (MxAxx) | Multi-unit Angular Adaptor (P14) |
|---|---|---|
| 510K | K220022 | K132125 |
| Raw Material | Ti6Al4V | Ti6Al4V |
| Microbial state /Sterilization method | Non-sterile / steam | Non-sterile / steam |
| Collar length (mm) | 1 mm, 2 mm, 3 mm, 4 mm | 1 mm, 3 mm |
| Platform | Standard | Standard |
| Diameter | 4 mm | 4 mm |
| Angle | 15° | 17°, 30° |
| Cement Retained | No | No |
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plant System
K220022
| Screw Retained | Yes | Yes |
|---|---|---|
| Sterility | Non-sterile | Non-sterile |
TRATE abutments are similar to the predicate abutments with insignificant difference in:
- angle. An engineering rationale shows that the angulation of the subject abutment is less than predicate, resulting in a shorter moment arm. Further, the wide diameter abutment has more material than a standard diameter abutment. Therefore, this abutment does not create a new, worst case.
- collar length. Adding longer collar length is addressed through bench testing (ISO 14801). Thus, established compatibility limitations to the angled abutments (MxAxx abutments are to be used only with implants 3.5 mm diameter or larger and only for multiple unit restorations).
- Material, manufacturing methods (including anodization), and sterility are substantial equivalent between the subject and predicate device
Similarities: Indications for Use
All devices are intended for surgical restorative applications for placement in the bone of the upper and lower jaw, to provide support for prosthetic devices, such as artificial teeth. Intended Use, intended and indications, and clinical application differ slightly in wording, but are fully equivalent on content level.
Technological Similarities:
All systems presented make use of the very same basic design consisting of full body, threaded, Titanium implants and abutments. All predicate devices (implants) are surface-treated to increase bone-implant contact, and hence facilitate osteointegration. All three use Gamma radiation to sterilize their implants. TRATE Dental Implant System Abutments are similar in design, technological characteristics and encompass dimensions as predicate abutments. No technological differences exist in materials, manufacturing technology, design or intended use. To improve the restorative process all systems offer angulated abutments are provided non-sterile to the end-user in a single-unit package, and are for single patient, singleuse only. Mechanical testing results demonstrate similar maximum loads.
Differences
When comparing the TRATE Dental Implants and abutments to similar cleared devices there are no technological, design or material differences. Indications for use are similar. The differences are in the dimensions of the subject devices which are within the range of predicate devices. The sterile barrier implant body packaging is also different than the predicate packaging but this difference is mitigated in the labeling difference between the TRATE Dental Implant System and the predicate device is that TRATE Dental Implant System is labeled as MR Conditional, which is addressed through scientific rationale and published literature evaluating the worst-case of the subject system. Due to the difference in sterile-barrier packaging, labeling differences also include handling for single-sterile barrier packaging.
Conclusion:
ROOTFORM Dental Implants and its predicate devices have the similar intended use, have similar technological characteristics, and are made of similar materials and surface treatments. All devices encompass the same range of physical dimensions, including diameter and length of
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Image /page/11/Picture/0 description: The image shows the logo for TRATE Dental Implant System. The word "TRATE" is in large, red, bold letters. To the right of the word "TRATE" are the words "Dental Implant System" in a smaller, black, bold font.
K220022
the implants, diameter and angulation of the abutments, and the materials and designs of abutments. All devices are packaged in similar materials and sterilized using similar methods.
§ 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.