(493 days)
No
The document describes standard dental implants and related components, focusing on materials, design, and sterilization. There is no mention of AI, ML, or any computational analysis of data for diagnosis, treatment planning, or device function.
Yes
The device is described as "dental implants and abutments" intended for "oral implantation to provide a support structure for connected prosthetic devices" to restore "chewing function" and facilitate "oral rehabilitation." These are functions that aim to restore normal body function, which classifies it as a therapeutic device.
No
This device is described as a dental implant system, including implants, abutments, and prosthetic parts, intended for the functional and esthetic oral rehabilitation of patients. Its purpose is to provide support for crowns or bridges, which is a therapeutic and restorative function, not a diagnostic one. No mention of diagnosis is present in the text.
No
The device description clearly outlines physical components like dental implants, abutments, healing caps, and screws, which are hardware. The performance studies also focus on testing of these physical components (sterilization, biocompatibility, surface characteristics).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "functional and esthetic oral rehabilitation" and providing "support for crowns or bridges." This describes a device used in vivo (within the body) for structural support and restoration, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details physical components like implants, abutments, healing caps, and screws, all designed for surgical implantation and mechanical function within the mouth. There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is clearly a medical device intended for surgical implantation and prosthetic support in the oral cavity.
N/A
Intended Use / Indications for Use
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.
Product codes
DZE, NHA
Device Description
The Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, and Proimtech Abutment Screw are components of a dental implant system. The Bilimplant® dental implants and abutments are intended for oral implantation to provide a support structure for connected prosthetic devices.
Bone Level Implants are designed for placement at the bone level and can be used in different bone types and regions of the upper and lower jaw. Due to their bone-level placement, they are suitable for aesthetic results, especially in the anterior regions of the jaws.
Tissue Level Implants have a 2.3 mm machined collar and are intended for posterior applications in the upper and lower jaw, particularly in cases with significant gingival tissue, to facilitate prosthetic procedures.
Straight Abutments are superstructure parts that support fixed partial dentures on a straight implant. They are used for single-member or bridge cemented restorations and come with varying gingival heights and diameters.
Healing Caps are screwed into the implant body after surgery to protect the internal structure of the implant. They are not used to support a prosthetic superstructure but are for transgingival healing and shaping of soft tissue during the healing process. They are designed to be compatible with both tissue level and bone level implants.
Abutment Screws connect and fix the abutment and implant body.
The implants are made of Grade 4 commercially pure titanium or Titanium-13 Zirconium alloy. They feature a Sand blasted Large grit Acid etched (SLA) or SLActive surface treatment. All components are for single use only. Implants are provided sterile (Gamma irradiation), while abutments, healing caps, and abutment screws are provided non-sterile, with recommended sterilization methods of Autoclave Moist Heat or Steam for end-users.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper or lower jaw, Maxillary and/or mandibular arches
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject device was evaluated and tested according to several guidance documents and standards, including "Root Form Endosseous Dental Implants and Endosseous Dental Implant Abutments" (May 12, 2004), "Use of International Standards of medical devices-Part 1: Evaluation and testing within a risk management process" (September 4, 2020), "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015), and "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions of Devices Labeled as Sterile" (January 21, 2016).
Non-clinical data presented included Gamma sterilization validation (ISO 1137-1 and ISO 11137-2), Bacterial Endotoxin Testing (BET) according to USP-43-NF38; 2020 and ASTM F1980, shelf life validation through packaging with ISO 1160, moist heat sterilization (ISO 17665-1 and ISO TS 17665-2), and biocompatibility testing (ISO 10993-5 and ISO 10993-12).
The endosseous threaded surface of the subject device, which is grit-blasted with non-resorbable aluminum oxide (Al2O3) particles, was validated by scanning electron microscope (SEM) and energy dispersive X-ray spectroscopy (EDS) characterization. Bacterial endotoxins in the sterile devices will be monitored, with a BET level of ≤ 20 EU/device.
No clinical data were included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K173961, K212533, K130222, K160850, K182448, K052957, K051636
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
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.
1
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.
2
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
3
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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5
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 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. |
| -------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
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8
| 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 | |
|---|---|---|---|---|---|---|
| Technologi | ||||||
| cal | ||||||
| Characteris | ||||||
| tics | Proimtech Dental Body Implant | |||||
| (K231100) | Straumann Bone Level Tapered | |||||
| Implants (K140878) | Straumann® Bone Level | |||||
| Tapered Implants (K140878) | Straumann® BLX Implant | |||||
| System (K173961) | BLX WB | |||||
| Ø5.0 (L18), | ||||||
| Ø5.5 and Ø6.5 | ||||||
| mm (L14 and L16) | ||||||
| Implants (K212533) | Straumann Dental Implant | |||||
| System SLActive and Roxolid | ||||||
| Product Families (K13022 |
- |
| Product
Code | 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).
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11
| Material | Grade 4 commercially pure titanium
conforming with ISO 5832-
2 | Grade 4 commercially pure
titanium conforming with ISO
5832-2 | Commercially pure grade 4
titanium & Titaniun-
13Zirconium alloy (Roxolid®) | Titanium
-13
Zirconium alloy (Roxolid
®) | Titanium-13
Zirconium alloy
(Roxolid®) | Titanium-13 Zirconium alloy
(Roxolid®) |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Surface
Treatment | Sand blasted Large grit Acid etched
(SLA) | Sand blasted Large grit Acid
etched (SLA) | SLA, SLActive | Hydrophilic SLActive® | Hydrophilic
SLActive® and SLA® | SLA,
SLActive |
| Design | Image: Implant | Image: Implant | Image: Implant | Image: Implant | Image: Implant | Image: Implant |
| Single
Use
Only | Yes | Yes | Yes | Yes | Yes | Yes |
| Transfer
piece | Fixture-mount transfer part, intended
to support the implant while in the
primary package, to aid in the
removal of the implant from the
primary package, and to aid in
placement of the implant into the
osteotomy site. | Snap fit mount Loxim™
transfer piece, intended to
support the implant while in
the primary package, to aid in
the removal of the implant
from the primary package, and
to aid in placement of the
implant into the osteotomy
site. | Fixture-mount transfer part,
intended to support the
implant while in the primary
package, to aid in the
removal of the implant from
the primary package, and to
aid in placement of the
implant into the osteotomy
site. | Fixture-mount transfer part,
intended to support the
implant while in the primary
package, to aid in the
removal of the implant from
the primary package, and to
aid in placement of the
implant into the osteotomy
site. | Fixture-mount
transfer part,
intended to support
the implant while in
the primary package,
to aid in the removal
of the implant from
the primary package,
and to aid in
placement of the
implant into the
osteotomy site. | Fixture-mount transfer part,
intended to support the
implant while in the primary
package, to aid in the
removal of the implant from
the primary package, and to
aid in placement of the
implant into the osteotomy
site. |
| | | | | | | |
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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, Ø6.5
mm | Ø4.1, Ø4.8
mm |
|------------------|---------------------|---------------|----------|----------------------|------------------------|------------------|
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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 mm
Ø5.5 and 6.5 mm: 14
and 16mm | 6, 8, 10, 12 mm |
|-------------------|-----------------------------|-----------------------------|-----------------------------|-----------------------------|---------------------------------------------------|-----------------------------|
| Sterilizatio
n | 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 Bilimplant | |
| Dental Implants in the maxillary and / or mandibular arches to provide support | ||
| for 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 Tpure | |
| Dental Implants in the maxillary and/or mandibular arches to provide support for | ||
| crowns, bridges or overdenture for edentulous or partially edentulous patients. | ||
| Straight: For single or multiple cement retained restorations Internal hex | ||
| connection. | ||
| 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 | ||
| Similarities | ||
| The device in question has the same characteristics compared to the reference device in the following aspects. Abutment Design, Material, Single use and Sterilization. | ||
| Difference | ||
| The 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.
17
Healing Cap
| SUBJECT DEVICE | REFERENCE DEVİCE | REFERENCE DEVICE | |
|---|---|---|---|
| Product Code | NHA | NHA | NHA |
| Device Name | Proimtech Healing Cap | Implantium Abutments | |
| (Healing Abutment) | CAMLOG Dental | ||
| Implant | |||
| Abutments, Healing | |||
| Caps, and | |||
| Accessories | |||
| 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 / or | ||
| mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients. | Implantium Prosthetics is | ||
| intended for use as an aid in | |||
| prosthetic rehabilitation. | CAMLOG | ||
| (Cylindrical, Wide | |||
| Body. Bottleneck) | |||
| displace the gingiva | |||
| from the space | |||
| above the | |||
| CAMLOG implant | |||
| or bar abutment | |||
| during the CAMLOG | |||
| implant healing | |||
| time and serve for | |||
| proper gingiva | |||
| shaping. | |||
| 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 |
| Recommended | |||
| Sterilization 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 / 5.75 | |||
| 6.50 / 6.54 / 6.64 / 6.75 / 7.64 | |||
| / 8.64 / 9.64 | 3.3. 3.8, 4.3. 5 and | ||
| 6mm | |||
| Cylindrical | |||
| 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 / 12.66 | |||
| 14.42 / 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 |
18
19
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.
20
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 Dental | |
| Implants in the maxillary and / or mandibular arches to provide support for crowns or bridges | ||
| for edentulous or partially edentulous patients. | Abutment Screw is used for securing the abutment to the | |
| endosseous 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.
21
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 , 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.