(493 days)
Indications for use Bilimplant® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
Bilimplant Abutments and Prosthetic parts are intended for use with Implants in the maxillary and / or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.
The Bilimplant® dental implants and abutments, which are models within the Proimtech Implant and Abutment system, are intended for oral implantation to provide a support structure for connected prosthetic devices.
Bone Level Implant: Thanks to its design features, it is placed completely at the bone level. It is produced to be applied in different bone types and different regions (anterior and posterior) in the lower and upper jaw. Since it is at the bone level, it can be used for more aesthetic results, especially in the front areas of the jaws (in the areas on the smile line).
Tissue Level Implant: The Tissue Level Implant has a 2.3 mm machined collar. It can be used in posterior applications in the upper and lower jaw where there are no aesthetic concerns, in different bone types and especially in cases with high gingival amount in order to facilitate prosthetic stages.
Straight Abutments: It is the superstructure part that supports fixed partial dentures manufacture on a straight implant. It is used in single member or bridge cemented restorations. Cement retained abutments have a different gingival height of 1-5 mm, diameters of 3.5, 4.5, 6 mm depending on the platform diameters.
Healing Caps: Following the second surgery of the gingiva in two-stage surgical procedures, and after the placement of the implant in single-stage surgeries, it is screwed into the implant body and protects the internal structure of the implant. It is not used to support a prosthetic superstructure. It is used for transgingival healing and shaping of soft tissue during the healing process of soft tissue. There are two different designs for healing caps in dental implant systems. These are manufactured to be compatible with tissue level and bone level implants.
Abutment Screws: Connects and fixes the abutment and implant body.
This is a 510(k) premarket notification for a medical device family consisting of Proimtech Dental Body Implants, Abutments, Healing Caps, and Abutment Screws. The provided document is an FDA clearance letter and a 510(k) Summary, which details the device's characteristics and its substantial equivalence to previously cleared devices.
The document does not describe a study proving the device meets specific acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity, as it is a medical device clearance for physical devices, not a diagnostic or AI-powered device.
Therefore, I cannot provide information on acceptance criteria and a study proving the device meets them in the context of diagnostic performance. The studies mentioned are related to material properties, sterilization, biocompatibility, and packaging, which are standard for dental implants.
However, I can extract the information provided regarding the testing and characterization of the device components, which serve as evidence for their safety and effectiveness in achieving substantial equivalence.
1. A table of acceptance criteria and the reported device performance
Since this is a physical medical device (dental implants and associated components) and not an AI/diagnostic device, the concept of "acceptance criteria" and "reported device performance" typically refers to engineering performance (e.g., strength, durability, biocompatibility) rather than diagnostic metrics. The document describes several tests conducted to ensure the device's fundamental characteristics are met:
| Acceptance Criteria (Implied from tests) | Reported Device Performance (Summary) |
|---|---|
| Sterilization: | |
| Valid Gamma Sterilization | Achieved according to ISO 11137-1 and ISO 11137-2 for device implants and screws. |
| Moist Heat Sterilization (End User) | Validated in accordance with ISO 17665-1 and ISO TS 17665-2 (to be performed by the end user for non-sterile components like abutments and healing caps). |
| Biocompatibility: | |
| Cytotoxicity | Tested in accordance with ISO 10993-5 (Biocompatibility Testing). |
| Sensitization/Irritation | Tested in accordance with ISO 10993-12 (Biocompatibility Testing). |
| Bacterial Endotoxin: | |
| Endotoxin Level (BET) | ≤ 20 EU/device (Monitored for devices provided sterile). Testing performed according to USP-43- NF38; 2020 <85> and LAL testing according to ASTM F1980. |
| Packaging & Shelf Life: | |
| Packaging Integrity | Shelf life validation through packaging with ISO 1160. |
| Material & Surface Characteristics (Implants): | |
| Material Composition | Grade 4 commercially pure titanium conforming with ISO 5832-2 (for implants). Ti-6Al-4V ELI (ASTM F136) for healing caps and abutment screws. Assessed for substantial equivalence. |
| Surface Treatment (SLA) | Validated using Scanning Electron Microscope (SEM) and Energy Dispersive X-ray Spectroscopy (EDS) for the grit-blasted with non-resorbable aluminum oxide (AI20) particles surface. (Implants) |
| Design Consistency | Comparisons of design features, diameters, and lengths with predicate devices were made. Differences were deemed not to affect substantial equivalence or product performance, "as a result of the tests conducted." (Specific performance tests for design features are not detailed, but implied by the conclusion of no significant difference). |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for these tests (e.g., how many implants were tested for sterilization or biocompatibility). This level of detail is typically found in the full test reports, not the 510(k) summary.
- Data provenance: The testing was conducted as part of the regulatory submission process for a manufacturer in Turkey (Proimtech Saglik Urunleri Anonim Sirketi, Istanbul, Turkey). The studies are non-clinical (laboratory-based) as explicitly stated: "No clinical data were included in this submission." The testing would be considered prospective in the sense that it was performed specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the type of device and studies described. "Ground truth" and "experts" in this context typically refer to diagnostic interpretation in AI or clinical studies. For physical device testing (material, sterilization, biocompatibility), the "ground truth" is established by adherence to international standards (e.g., ISO, ASTM, USP) and the results are interpreted by qualified laboratory personnel, not by a panel of medical experts establishing a "ground truth" for a diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for non-clinical, laboratory-based testing of physical medical device properties. Adjudication methods are typically used in clinical trials or diagnostic performance studies to resolve discrepancies in expert opinions or outcomes.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. MRMC studies are used to evaluate the interpretive performance of readers (e.g., radiologists) with and without assistance from an AI device for diagnostic tasks. The Proimtech Dental Body Implant system is a physical dental implant and prosthetic components, not a diagnostic AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical implant, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As explained in point 3, the concept of "ground truth" in the context of diagnostic devices is not applicable here. For the non-clinical tests conducted, the "ground truth" is defined by the objective measurement criteria and specifications outlined in the referenced international standards (e.g., ISO 11137 for sterilization, ISO 10993 for biocompatibility) and scientific analytical methods (e.g., SEM/EDS for surface characterization). Compliance with these standards is the "ground truth" for the device's physical and biological properties.
8. The sample size for the training set
This is not applicable. This device is a physical medical implant, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for a machine learning model.
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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 and 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.
August 23, 2024
Proimtech Saglik Urunleri Anonim Sirketi Hakan Cevik General Manager Imes Sitesi, No:3 Dudullu Osb Mahallesi Imes 305.Sokak Istanbul. Istanbul 34773 TURKEY
Re: K231100
Trade/Device Name: Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: September 25, 2023 Received: July 31, 2024
Dear Hakan Cevik:
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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3
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 -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) K231100
Device Name
Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw
Indications for Use (Describe)
Indications for use Bilimplant® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
Bilimplant Abutments and Prosthetic parts are intended for use with Implants in the maxillary and / or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary 510k K231100 Dental Body Implant Proimtech Saglik Urunleri Anonim Sirketi August 23, 2024
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | PROIMTECH SAGLIK URUNLERI ANONIM SIRKETI |
|---|---|
| Adress: | Dudullu OSB Mahallesi İmes Sanayi Sitesi 305. Sokak C Blok NO:3, Ümraniye, İstanbul |
| Telephone: | (0216) 999 50 41 |
| Fax: | |
| Official Contact: | Hakan Cevik, General Manager of Proimtech Saglik Urunleri Anonim Sirketi |
| Phone Number: | +90 535 355 51 00 |
| E-Mail: | hakancevik@bilimplant.com |
DEVICE NAME AND CLASSIFICATION
Device Trade Name: Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw
Common Name: Dental Body Implant, Abutment, Healing Cap, Abutment Screw,
Classification Name: Dental Body Implant, Endosseous dental implant (21 CFR 872.3640),
| Device Class: | II |
|---|---|
| Product Code: | DZE |
| Regulation Number: | 872.3640 |
| Review Panel: | Dental |
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Legally Marketed Device to Which Claim Substantial Equivalence:
for; Primary Predicate Device Implant Body: K140878, STRAUMANN BONE LEVEL TAPERED IMPLANT
for; Reference Device Implant Body: K173961, Straumann® BLX Implant System
for; Reference Device Implant Body: K212533, BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants
for; Reference Device Implant Body: K130222, Straumann Dental Implant System SLActive and Roxolid Product Families
for; Reference Device Abutment: K160850, Nucleoss Abutment System SANLILAR TIBBI CIHAZLAR MED. KIM.SAN.TIC.LTD.STI
for; Reference Device Abutment Screw: K182448, MegaGen Implant Co., Ltd.
for; Reference Device Healing Cap: K052957, Dentium Implantium® & SuperLine® Prosthetics
for; Reference Healing Cap: K051636, CAMLOG Dental Implant Abutments, Healing Caps, and Accessories
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INDICATIONS FOR USE STATEMENT
Dental Body Implant:
Indications for use Bilimplant® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth restorations and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
For Abutment Healing Cap Abutment Screw:
Indications:
Bilimplant Abutments and Prosthetic parts are intended for use with Bilimplants in the maxillary and / or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.
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2. Intended Use
The Bilimplant® dental implants and abutments, which are models within the Proimtech Implant and Abutment system, are intended for oral implantation to provide a support structure for connected prosthetic devices.
| PRODUCT NAME | INTENDED USE |
|---|---|
| Bone Level Implant | Thanks to its design features, it is placed completely at the bone level. It is produced to be applied in different bone types and different regions (anterior and posterior) in the lower and upper jaw. Since it is at the bone level, it can be used for more aesthetic results, especially in the front areas of the jaws (in the areas on the smile line). |
| Tissue Level Implant | The Tissue Level Implant has a 2.3 mm machined collar. It can be used in posterior applications in the upper and lower jaw where there are no aesthetic concerns, in different bone types and especially in cases with high gingival amount in order to facilitate prosthetic stages. |
| PRODUCT GROUP | INTENDED USE |
|---|---|
| Straight Abutments | It is the superstructure part that supports fixed partialdentures manufacture on a straight implant. It is used in singlemember or bridge cemented restorations. Cement retainedabutments have a different gingival height of 1-5 mm,diameters of 3.5, 4.5, 6 mm depending on the platformdiameters. |
| Healing Caps | Following the second surgery of the gingiva in two-stagesurgical procedures, and after the placement of the implantin single-stage surgeries, it is screwed into the implant bodyand protects the internal structure of the implant. It is notused to support a prosthetic superstructure. It is used fortransgingival healing and shaping of soft tissue during thehealing process of soft tissue. There are two different designsfor healing caps in dental implant systems. These aremanufactured to be compatible with tissue level and bonelevel implants. |
|---|---|
| -------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
4
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| Abutment Screws | Connects and fixes the abutment and implant body. |
|---|---|
| ----------------- | --------------------------------------------------- |
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Dental Implant
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | REFERENC E DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | |
|---|---|---|---|---|---|---|
| TechnologicalCharacteristics | Proimtech Dental Body Implant(K231100) | Straumann Bone Level TaperedImplants (K140878) | Straumann® Bone LevelTapered Implants (K140878) | Straumann® BLX ImplantSystem (K173961) | BLX WBØ5.0 (L18),Ø5.5 and Ø6.5mm (L14 and L16)Implants (K212533) | Straumann Dental ImplantSystem SLActive and RoxolidProduct Families (K130222) |
| ProductCode | DZE | DZE | DZE | DZE | DZE | DZE |
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Indications for use Bilimplant® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for singletooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
Indications
for Use
Indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases
Straumann® dental implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.
Straumann BLX Implants are suitable for endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients. BLX Implants can be placed with immediate function on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding abutment components.
Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
Straumann® Dental implants are indicated for oral endosteal implantation in the upper and lower jaw arches for the functional and aesthetic oral rehabilitation of edentulous and partially dentate patients. Straumann® Dental implants are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments).
7
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| Material | Grade 4 commercially pure titaniumconforming with ISO 5832-2 | Grade 4 commercially puretitanium conforming with ISO5832-2 | Commercially pure grade 4titanium & Titaniun-13Zirconium alloy (Roxolid®) | Titanium-13Zirconium alloy (Roxolid®) | Titanium-13Zirconium alloy(Roxolid®) | Titanium-13 Zirconium alloy(Roxolid®) |
|---|---|---|---|---|---|---|
| SurfaceTreatment | Sand blasted Large grit Acid etched(SLA) | Sand blasted Large grit Acidetched (SLA) | SLA, SLActive | Hydrophilic SLActive® | HydrophilicSLActive® and SLA® | SLA,SLActive |
| Design | Image: Implant | Image: Implant | Image: Implant | Image: Implant | Image: Implant | Image: Implant |
| SingleUseOnly | Yes | Yes | Yes | Yes | Yes | Yes |
| Transferpiece | Fixture-mount transfer part, intendedto support the implant while in theprimary package, to aid in theremoval of the implant from theprimary package, and to aid inplacement of the implant into theosteotomy site. | Snap fit mount Loxim™transfer piece, intended tosupport the implant while inthe primary package, to aid inthe removal of the implantfrom the primary package, andto aid in placement of theimplant into the osteotomysite. | Fixture-mount transfer part,intended to support theimplant while in the primarypackage, to aid in theremoval of the implant fromthe primary package, and toaid in placement of theimplant into the osteotomysite. | Fixture-mount transfer part,intended to support theimplant while in the primarypackage, to aid in theremoval of the implant fromthe primary package, and toaid in placement of theimplant into the osteotomysite. | Fixture-mounttransfer part,intended to supportthe implant while inthe primary package,to aid in the removalof the implant fromthe primary package,and to aid inplacement of theimplant into theosteotomy site. | Fixture-mount transfer part,intended to support theimplant while in the primarypackage, to aid in theremoval of the implant fromthe primary package, and toaid in placement of theimplant into the osteotomysite. |
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| Diameter(mm) | 3.7, 4.1, 4.8, 5.5, | 3.3, 4.1, 4.8 | 4.1, 4.8 | Ø 4.5, Ø5.5, Ø6.5 mm | Ø5.0, Ø5.5, Ø6.5mm | Ø4.1, Ø4.8mm |
|---|
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| Length(mm) | 8, 10,12, 14 | 8, 10, 12, 14 | 8, 10, 12, 14 | 6 to 18 mm | Ø5.0 mm: 18 mmØ5.5 and 6.5 mm: 14and 16mm | 6, 8, 10, 12 mm |
|---|---|---|---|---|---|---|
| Sterilization | Sterile (Gamma irradiation) | Sterile (Gamma irradiation) | Sterile (Gamma irradiation) | Sterile (Gamma irradiation) | Sterile (Gamma irradiation) | Sterile (Gamma irradiation) |
Substantial Equivalence Discussion
Similarities
The device has the same characteristics compared to the following aspects. Indication for Use, Design, Material, Surface Transfer Part and Sterlization.
Difference
The diameter and length directions of the different from the reference device. However, as a esult of the tests conduced, it was cecided hat there was no significat difference in product performance and that this difference did not affect substantial equivalence.
Reference to fully edentulous patients is not necessary because the subject device is intended for fully edertulous patients, it is not intended for full-arch restorations.
Discussion
On the basis of the above discussion, it is concluded that the device in question is substantially equivalent to the reference device.
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Abutment
| Technological Characteristics | SUBJECT DEVICE | REFERENCE DEVICE |
|---|---|---|
| Proimtech Abutment | Nucleoss Abutment System (K160850) | |
| Product Code | NHA | NHA |
| Indications for Use | Bilimplant Abutments and Prosthetic parts are intended for use with BilimplantDental Implants in the maxillary and / or mandibular arches to provide supportfor crowns or bridges for edentulous or partially edentulous patients.Straight: Internal quadrilateral connection for single or multiple cement-retained restorations. | Nucleoss Abutments and Prosthetic parts are intended for use with Nucleoss TpureDental Implants in the maxillary and/or mandibular arches to provide support forcrowns, bridges or overdenture for edentulous or partially edentulous patients.Straight: For single or multiple cement retained restorations Internal hexconnection. |
| Abutment Design | ||
| Material | ||
| Titanium alloy | Titanium alloy | |
| Abutment Platform Diameter (mm) | Straight: 3.5, 4.5, 5, 6 | Straight: 4.2, 5.0 6.0 |
| Abutment Platform Heights (mm) | Straight: 5.5, 7 | Straight: 1.0, 2.0, 3.0, 5.0 |
| Gingival Height | 1, 2, 3, 4 and 5 mm | 1, 1.5, 2, 3, 4, 4.5 and 5 mm |
| Single Use Only | Yes | Yes |
| Sterilization | Provided non- sterile | Provided non-sterile |
| Recommended Sterilization Method | Autoclave Moist Heat or Steam | Autoclave Moist Heat or Steam |
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| Design | ||
|---|---|---|
| Substantial Equivalence Discussion | ||
| SimilaritiesThe device in question has the same characteristics compared to the reference device in the following aspects. Abutment Design, Material, Single use and Sterilization.DifferenceThe connection type of the device in question is Four Corner Connection Type. Abutment Platform Diameter and Abutment Platform Heights are slightly different from the reference device.However, as a result of the tests, it was decided that there was no significant difference in product performance and that this difference did not affect the substantial equivalence. |
Discussion
On the basis of the above discussion, it is concluded that the device in question is substantially equivalent to the reference device.
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Healing Cap
| SUBJECT DEVICE | REFERENCE DEVİCE | REFERENCE DEVICE | |
|---|---|---|---|
| Product Code | NHA | NHA | NHA |
| Device Name | Proimtech Healing Cap | Implantium Abutments(Healing Abutment) | CAMLOG DentalImplantAbutments, HealingCaps, andAccessories |
| Manufacturer | PROIMTECH SAGLIK URUNLERI ANONIM SIRKETI | Dentium Co., Ltd. | Altatec GmbH |
| 510(k) Number | K231100 | K052957 | K051636 |
| Indication for use | Bilimplant Abutments and Prosthetic parts are intended for use with Bilimplant Dental Implants in the maxillary and / ormandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients. | Implantium Prosthetics isintended for use as an aid inprosthetic rehabilitation. | CAMLOG(Cylindrical, WideBody. Bottleneck)displace the gingivafrom the spaceabove theCAMLOG implantor bar abutmentduring the CAMLOGimplant healingtime and serve forproper gingivashaping. |
| Materials | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) | Titanium Alloy Ti-6Al-4V ELI |
| Connection type | Internal | Internal | Internal |
| Sterilization | Non-sterile | Non-sterile | Sterile |
| RecommendedSterilization Method | Autoclave Moist Heat or Steam | Autoclave Moist Heat or Steam | Gamma Irradiation |
| Single Use Only | Yes | Yes | Yes |
| Diameter | 3.5, 4.5, 4.8, 5, 5.4, 6.5 | 4.04 / 4.10 / 4.14 / 4.20 / 4.50/ 4.54 / 4.64 / 4.70 / 5.50 /5.54 / 5.64 / 5.756.50 / 6.54 / 6.64 / 6.75 / 7.64/ 8.64 / 9.64 | 3.3. 3.8, 4.3. 5 and6mmCylindrical |
| Length | 4.70, 5.10, 5.40, 6.20, 6.50, 6.90, 7.20, 7.50, 8, 8.20, 8.40, 8.50, 9, 9.40, 9.70, 10, 10.20, 10.40, 10.50, 11, 11.20,11.40, 11.50, 11.70, 12, 12.50 | 8.70 / 10.91 / 10.93 / 11.04 /11.15 / 12.41 / 12.44 / 12.55 /12.65 / 12.6614.42 / 14.44 / 14.55 / 14.66 | 2, 4 and 6mm |
| Gingival Height | 1, 2, 2.5, 3, 4, 5, and 6 mm | 3, 4, 5 and 7 mm | 2, 4 and 6 mm |
| Design | Image: silver colored implant abutment | Image: gray colored implant abutment |
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Similarities
The device in question has the same characteristics compared to the following aspects. Design, Material, Connection Type, Single use and Sterlization. Difference
The diameter and length different in question are sightly different from the reference in significant difference in product performance and this ofference does not affect the substantial equivalence.
Discussion
On the basis of the above discussion, it is conduded that the device in question is substantially equivalent to the reference device.
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Abutment Screw
| SUBJECT DEVICE | REFERENCE DEVICE | |
|---|---|---|
| Product Code | NHA | NHA |
| Device Name | Proimtech Abutment Screw | Abutment Screw |
| Manufacturer | PROIMTECH SAGLIK URUNLERI ANONIM SIRKETI | MegaGen Implant Co., Ltd. |
| 510(k) Number | K231100 | K182448 |
| Indication for use | Bilimplant Abutments and Prosthetic parts are intended for use with Bilimplant DentalImplants in the maxillary and / or mandibular arches to provide support for crowns or bridgesfor edentulous or partially edentulous patients. | Abutment Screw is used for securing the abutment to theendosseous implant. |
| Materials | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) |
| Connection Interface | External Conical Connection | Internal Conical Connection |
| Sterilization | Non-sterile | Non-sterile |
| Recommended Sterilization Method | Autoclave Moist Heat or Steam | Autoclave Moist Heat or Steam |
| Single Use Only | Yes | Yes |
| Surface Treatment | Machined, Anodizing | Machined |
| Diameter | 2, 2.2, 2.3 | 2.2 |
| Length | 4.50, 5.50, 7.90, 8.10 | 7.9 |
| Design | ||
| Substantial Equivalence Discussion |
Similarities
The device in question has he same charace device in the following appects. Indication for Use, Jesign, Material, Surface Treation. Difference
The dianeter, length dinerisons and connection are slight) different from the reference device. Howeve, there in o significant difference in product performance and this difference does not affect the substantial equivalence.
Discussion
On the basis of the above discussion, it is concluded that the device in question is substantially equivalent to the reference device.
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PERFORMANCE DATA
The subject device was evaluated and tested as recomments Root Form Endosseous Dental Implants and Endosseous Dertal Implant Alauthents lissued May 12,2004), Use of International Standation of medical devices- Part 1: Evaluation and testing within a risk management process" (issued September 4,2020), Reprocessing Meath Care settings: Validation Methods and Labelling (issued March 17, 2015), Submission and Review of Sterlity Information in Peemarket Notification (510(k) Submissions of Devices Labeled as Sterile (issued January 21,2016), and Progen and Answer (issued June 2012).
Non-dinical data presented to demonstration waldet Gamma sterlization validation for device implants and valve screws according to O 1137-1 and ISO 11137-2; Bacterial endotoxin (BET) testing, including time (LAL) testing according to USP-43- NF38; 2020 <85>, in accordance with ASTM F1980 and shel life validation through packaging vith ISO 1160; moist heat sterilization in accordance with ISO 17665-1 and ISO TS 17665-2 (to be performed by the end used; biocompatibility testing in accordance with ISO 10993-5 and ISO 10993-12.
The endosseus threaded surface of the subject is grit-blasted with non-resorbable aluminum oxide (AI20) particles; this surface was valiated by scanning electron microscope (SEM) and energy dispersive X-ray spectroscopy (EDS) characterization. Bacterial endotoxins in the subject devices provided sterile to the end user will be monitored and BET level of ≤ 20 EU/device.
No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICES
The subject devices are broadly equivalent in inciples to the primary predecessor and reference devices listed above. At the beginning of this unmary is a table compaing the Indications for Use and table tharacteristics of the subject device, the primary precursor devices.
The Indications for Use Statement (FUS) of the substantially equivalent to that of the primary precursor devices KL7396, K212553, K18022, K160850, K182448, K152957, K05166510. Minor differ its intentified intended use as an endosseus dertal inqlant and dental implant abutments to support a prosthesis to restore masticatory function.
There are minor differences between the FUS of the primary predicate device. These minor differences do not raise new safety or efficacy questions as the IFUS states equivalent intended use.
CONCLUSION
The subject device, the primary predicate devices have the same intended use, have similar technological characteristics, and are made of similar materials. The subject device, the primary predicate devices encompass the same rage of physical dimensions, are paraged in similar materials, and are sterilized using similar method. This submission demonstrate substantial equivalence to the predicate devices listed above.
§ 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.